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CERTIFICATE OF ANALYSIS PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18234C EXP. DATE: 8/2020 TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.2 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 64 Count at 45 minutes: 52 PASSES < 20% DECREASE WS cSOP 24.3; 54.0 STERILITY PASSES <1 x10 -6 AAMI** VALIDATED Gamma Irradiated (Certificate) FILL VOLUME CONFORMS LABEL +/- 2 ml WS cSOP 9.4; 13.4 COLOR CONFORMS CLEAR NO FOREIGN MATTER VISUAL WS cSOP 33.2 PACKAGE INTEGRITY SHIPPER CONFORMS NO VISIBLE DAMAGE TO CARTON VISUAL WS cSOP 15.3 PACKAGE INTEGRITY BOTTLE CONFORMS NO LEAKING WS cSOP 14.4 PACKAGE MARKINGS CONFORMS CONFORMS TO STANDARD WS cSOP 5.5 BOTTLE MARKINGS CONFORMS CONFORMS TO STANDARD WS cSOP 5.5; 6.4; 38.2 *TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories. **Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137- 1994; microbiological testing method AAMI TIR 8-1991. Joseph Zindulis, Ph.D. Production Manager October 3, 2018 Made By: Weber Scientific 2732 Kuser Road Hamilton, NJ 08691 (609) 584-7677

TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

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Page 1: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18234C EXP. DATE: 8/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 64

Count at 45 minutes: 52

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

October 3, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 2: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18235C EXP. DATE: 8/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 64

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

October 3, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 3: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18236C EXP. DATE: 8/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 72

Count at 45 minutes: 58

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

October 3, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 4: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18239C EXP. DATE: 8/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 68

Count at 45 minutes: 64

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

October 25, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 5: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18240C EXP. DATE: 8/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 73

Count at 45 minutes: 70

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

October 25, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 6: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18248C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 74

Count at 45 minutes: 64

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 2, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 7: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18249C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 57

Count at 45 minutes: 52

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 2, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 8: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18250D EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 73

Count at 45 minutes: 72

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 6, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 9: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18253C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 66

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 6, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 10: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18254C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 68

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 6, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 11: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18255C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 75

Count at 45 minutes: 70

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 6, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 12: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18256C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 70

Count at 45 minutes: 67

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 8, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 13: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18260C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 57

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 8, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 14: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18262C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 57

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 15, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 15: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18263C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 62

Count at 45 minutes: 59

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 15, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 16: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18267C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 57

Count at 45 minutes: 56

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 15, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 17: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18269C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 66

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 19, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 18: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18270C EXP. DATE: 9/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

November 19, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 19: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18274C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 68

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 4, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 20: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18277C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 58

Count at 45 minutes: 56

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 4, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 21: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18281C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 77

Count at 45 minutes: 62

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 5, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 22: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18283C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 69

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 5, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 23: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18284C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 60

Count at 45 minutes: 67

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 7, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 24: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%
Page 25: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18290C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 78

Count at 45 minutes: 71

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 11, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 26: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18292C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 70

Count at 45 minutes: 71

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 11, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 27: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18295C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 70

Count at 45 minutes: 69

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 11, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 28: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18298C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 65

Count at 45 minutes: 54

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 13, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 29: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18299C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 61

Count at 45 minutes: 64

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 13, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 30: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18302C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 61

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 19, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 31: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18303C EXP. DATE: 10/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 59

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 19, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 32: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18309C EXP. DATE: 11/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 65

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 19, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 33: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18311C EXP. DATE: 11/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 48

Count at 45 minutes: 55

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

December 19, 2018

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 34: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18316C EXP. DATE: 11/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

January 4, 2019

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 35: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18325C EXP. DATE: 11/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 64

Count at 45 minutes: 65

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

January 4, 2019

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 36: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18330C EXP. DATE: 11/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 74

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

January 4, 2019

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 37: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18333C EXP. DATE: 11/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 61

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

January 31, 2019

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 38: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18334C EXP. DATE: 11/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 59

Count at 45 minutes: 65

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

January 31, 2019

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 39: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18337C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 61

Count at 45 minutes: 64

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 1, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 40: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18338C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 59

Count at 45 minutes: 69

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 1, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 41: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18340C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 61

Count at 45 minutes: 68

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 1, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 42: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18341A EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 64

Count at 45 minutes: 67

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 6, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 43: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18344C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 75

Count at 45 minutes: 89

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 6, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 44: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18345C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 69

Count at 45 minutes: 77

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 6, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 45: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18347C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 55

Count at 45 minutes: 62

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 11, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 46: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18348C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 68

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 11, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 47: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18351C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 66

Count at 45 minutes: 69

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 22, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 48: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18352C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 56

Count at 45 minutes: 65

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 11, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 49: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18354C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 60

Count at 45 minutes: 62

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 15, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 50: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18355C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 60

Count at 45 minutes: 69

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 15, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 51: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18358C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 67

Count at 45 minutes: 61

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 15, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 52: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18360C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 72

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 22, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 53: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18362C EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 72

Count at 45 minutes: 62

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 22, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 54: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 18365A EXP. DATE: 12/2020

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 66

Count at 45 minutes: 68

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 22, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 55: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19002C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 67

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 28, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 56: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19003C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 69

Count at 45 minutes: 74

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 28, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 57: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19004C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 61

Count at 45 minutes: 68

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 28, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 58: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19007A EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 65

Count at 45 minutes: 83

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 28, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 59: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19008C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 61

Count at 45 minutes: 70

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 28, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 60: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19010C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 64

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 28, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 61: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19011C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 57

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 28, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 62: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19014C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 57

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

February 28, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 63: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19021C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 60

Count at 45 minutes: 56

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

March 1, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 64: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19022C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 71

Count at 45 minutes: 64

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

March 1, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 65: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19023C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 79

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

March 1, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 66: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19024C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 60

Count at 45 minutes: 54

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

March 1, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 67: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19028C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 73

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

March 14, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 68: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19030C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 57

Count at 45 minutes: 65

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

March 14, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 69: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19031C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 67

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

March 14, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 70: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19035C EXP. DATE: 01/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 73

Count at 45 minutes: 80

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

March 14, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 71: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19038C EXP. DATE: 02/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 56

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 5, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 72: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19042C EXP. DATE: 02/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 68

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 5, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 73: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19043D EXP. DATE: 02/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.1

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 65

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 5, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 74: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19044C EXP. DATE: 02/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.0

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 49

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 5, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 75: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19066C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 55

Count at 45 minutes: 64

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 18, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 76: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19070C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 55

Count at 45 minutes: 52

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 18, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 77: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19071C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 60

Count at 45 minutes: 65

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 18, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 78: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19072C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 57

Count at 45 minutes: 48

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 23, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 79: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19073C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 59

Count at 45 minutes: 61

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 23, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 80: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19078C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 23, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 81: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19084C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 56

Count at 45 minutes: 54

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 26, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 82: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19085C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 52

Count at 45 minutes: 53

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 26, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 83: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19087C EXP. DATE: 03/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 51

Count at 45 minutes: 51

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

April 26, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 84: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19092C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 60

Count at 45 minutes: 53

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

May 7, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 85: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19093C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 53

Count at 45 minutes: 53

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

May 7, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 86: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19094C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 61

Count at 45 minutes: 58

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

May 9, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 87: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19095C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 49

Count at 45 minutes: 60

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

May 9, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 88: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19101C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 54

Count at 45 minutes: 70

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

May 23, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 89: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19105C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 64

Count at 45 minutes: 64

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

May 23, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 90: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19106C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 60

Count at 45 minutes: 62

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

May 31, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 91: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19108C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 59

Count at 45 minutes: 55

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 5, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 92: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19113C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 69

Count at 45 minutes: 69

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 5, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 93: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19114C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 65

Count at 45 minutes: 56

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 5, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 94: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19115C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 59

Count at 45 minutes: 73

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 5, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 95: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19116D EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 59

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 7, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 96: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19119C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.2

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 54

Count at 45 minutes: 69

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 7, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 97: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19120C EXP. DATE: 04/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 48

Count at 45 minutes: 53

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 7, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 98: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19121C EXP. DATE: 05/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 53

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 7, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 99: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19022C EXP. DATE: 05/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 55

Count at 45 minutes: 75

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 27, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 100: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19126C EXP. DATE: 05/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 62

Count at 45 minutes: 52

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

July 10, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 101: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19127C EXP. DATE: 05/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 63

Count at 45 minutes: 55

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 27, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 102: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19129C EXP. DATE: 05/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 62

Count at 45 minutes: 63

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 27, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 103: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19130C EXP. DATE: 05/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.4

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 78

Count at 45 minutes: 66

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 27, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677

Page 104: TEST RESULTS SPECIFICATION METHOD · TEST RESULTS SPECIFICATION METHOD pH @ 25 C 7.1 7.2 +/- 0.2 WS cSOP 8.4 TOXICITY* Count at 0 minutes: 66 Count at 45 minutes: 66 PASSES < 20%

CERTIFICATE OF ANALYSIS

PRODUCT DESCRIPTION: Weber Scientific Phosphate Butterfield Buffer

CATALOG No. 3127-14 VOLUME (ml) 99 LOT No. 19133C EXP. DATE: 05/2021

TEST

RESULTS

SPECIFICATION

METHOD

pH @ 25 C

7.3

7.2 +/- 0.2

WS cSOP 8.4

TOXICITY*

Count at 0 minutes: 61

Count at 45 minutes: 67

PASSES

< 20% DECREASE

WS cSOP 24.3; 54.0

STERILITY

PASSES

<1 x10-6

AAMI** VALIDATED

Gamma Irradiated

(Certificate)

FILL VOLUME

CONFORMS

LABEL +/- 2 ml

WS cSOP 9.4; 13.4

COLOR

CONFORMS

CLEAR

NO FOREIGN

MATTER

VISUAL

WS cSOP 33.2

PACKAGE

INTEGRITY

SHIPPER

CONFORMS

NO VISIBLE

DAMAGE TO

CARTON

VISUAL

WS cSOP 15.3

PACKAGE

INTEGRITY

BOTTLE

CONFORMS

NO LEAKING

WS cSOP 14.4

PACKAGE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5

BOTTLE

MARKINGS

CONFORMS

CONFORMS

TO STANDARD

WS cSOP 5.5; 6.4; 38.2

*TEST PERFORMED AT COMMERCIAL LAB: New Jersey Laboratories.

**Association for the Advancement of Medical Instrumentation validation method ANSI/AAMI/ISO 11137-

1994; microbiological testing method AAMI TIR 8-1991.

Joseph Zindulis, Ph.D.

Production Manager

June 27, 2019 .

Made By:

Weber Scientific

2732 Kuser Road

Hamilton, NJ 08691

(609) 584-7677


Specification of Flash EEPROM Emulation · 2017. 10. 20. · Specification of Flash EEPROM Emulation V3.1.1 R4.1 Rev 3 4 of 66 Document ID 286: AUTOSAR_SWS_FlashEEPROMEmulation -

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