Cal X Tablet (2004)

ESKAYEF BANGLADESH LIMITED400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur.

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Batch Size : 500000 Tablet Analytical Ref. No. :FP0427/2005

Batch No. : 2005 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X

Mfg. Date : May 12

Date Sampled : 26.05.12 to 28.05.12 Date of Analysis : 26.05.12 to 04.06.12 Exp Date : May /14

Tests Results

1 Description White to off white RFBE Tablet Complies

2 Identity Same Complies

3 Average weight 60.00 mg

4 Uniformity of weight 58.00 - 62.00 mg

5 Water Cotent(KF) / LOD% 5.35%

6 Diameter 5.00 - 5.40 mm 5.20 - 5.21 mm

7 Hardness 1.00 - 5.00 kp 2.80 - 4.60 Kp

8 Thickness 1.90 - 2.60 mm 2.12 - 2.27 mm

9 Disintegration time NMT 15.00 minutes (BP) 60 - 85 sec

10 Dissolving time with stirring NMT 90 sec 40 - 45 sec

11 Friability NMT 1.00 % (BP ) 0.07 - 0.08 %

12 Assay 5.85 - 7.15 mg / tablet 6.36 mg tab

Released for use

Rejected

CERTIFICATE OF ANALYSIS PRODUCT

Product : Cal X Tablet

Sl. No.

SK+F Specifications

NMT + 2.50 % of theoretical weight ( 58.00 - 62.00

NMT 2 of 20 may vary from average wt. by more than ± 10 %( 54.00 - 66.00) but none should vary

by more than ± 20% ( 48.00 - 72.00 )mg

[ Ref : BP ]

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

Remarks : Ok Reference : Book -219 ; Page - 151

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

CERTIFICATE OF ANALYSIS

Tests Specifications Results

1 Description Complies

4 Uniformity of weight

5 Water Cotent(KF) / LOD% KF: 5.70%

6 Diameter 5.00 - 5.40 mm 5.20 - 5.22 mm

7 Hardness 1.00 - 5.00 kp 3.10 - 3.50 kp

8 Thickness 1.90 - 2.60 mm 2.21 - 2.23 mm

9 Disintegration time NMT 15.00 minutes 40 - 60 sec

11 Friability NMT 1.00% 0.18 - 0.22 %

12 Assay 5.85 - 7.15 mg / tablet 6.34 mg / tablet

Product Name : Cal X Tablet Label claim : Sucralose NF 6.5 mg / tablet Sample SIze : 300 Tablets Batch No. : 2004 Mfg. Date : April 12 Exp. Date : April 14 Date of Analysis : 28.06.12 to 30.06.12

Sl. No.

White to off white RFBE Tablet

Theoretical weight ± 2.50% (58.00 - 62.00) mg

NMT 2 of 20 may vary from average wt. by ± 10% (54.00 - 66.00) mg but none should vary by ± 20%

(48.00 - 72.00) mg

Complies (Min: 59.75 mg and Max.: 61.43 mg)

KF: (3.50 - 6.50)% LOD: (1.50 - 3.50)%

Remarks : OK

Prepared by Lecturer

Dept. of Pharmaceutical Technology

Checked by Lecturer Dept. of Pharmaceutical Technology

Approved by Chairman Dept. of Pharmaceutical Technology

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Apr /12

Date Sampled : 26.04.12 to 29.04.12 Date of Analysis : 26.04.12 to 07.05.12 Exp Date : Apr /14

Tests Results

6 Diameter 5.00 - 5.40 mm 5.20 - 5.22 mm

7 Hardness 1.00 - 5.00 kp 2.80 - 4.10 Kp

8 Thickness 1.90 - 2.60 mm 2.18 - 2.24 mm

10 Dissolving time with stirring NMT 90 sec 80 sec

Released for use

Rejected

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

[ Ref : BP ]

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Jan /12

Date Sampled : 16.01.12 to 17.01.12 Date of Analysis : 17.01.12 to 18.01.12 Exp Date : Jan /14

Tests Results

6 Diameter 5.00 - 5.40 mm 5.20 - 5.21 mm

7 Hardness 1.00 - 5.00 kp 2.70 - 4.10 Kp

8 Thickness 1.90 - 2.60 mm 2.20 - 2.28 mm

Released for use

Rejected

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

[ Ref : BP ]

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Jan /12

Date Sampled : 16.01.12 to 17.01.12 Date of Analysis : 16.01.12 to 18.01.12 Exp Date : Jan /14

Tests Results

6 Diameter 5.00 - 5.40 mm 5.20 - 5.21 mm

7 Hardness 1.00 - 5.00 kp 2.40 - 4.40 Kp

8 Thickness 1.90 - 2.60 mm 2.20 - 2.28 mm

Released for use

Rejected

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

[ Ref : BP ]

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Batch Size : Tablet Analytical Ref. No. :FP0427/

Batch No. : Label claim : Sucralose NF 6.5 mg/ tablet Overage : X

Mfg. Date :

Date Sampled : Date of Analysis : Exp Date :

Tests Results

1 Description White to off white RFBE Tablet

2 Identity Same

3 Average weight

4 Uniformity of weight

5 Water Cotent(KF) / LOD%

6 Diameter 5.00 - 5.40 mm

7 Hardness 1.00 - 5.00 kp

8 Thickness 1.90 - 2.60 mm

9 Disintegration time NMT 15.00 minutes (BP)

10 Dissolving time with stirring NMT 90 sec

11 Friability NMT 1.00 % (BP )

12 Assay 5.85 - 7.15 mg / tablet

Released for use

Rejected

Sl. No.

SK+F Specifications

NMT 2 of 20 may vary from average wt. by more than ± 10 %( but none should vary by more than ±

20% mg [ Ref : BP ]

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

Remarks : Ok Reference : Book - ; Page -

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Batch Size : 500,000 Tablet Analytical Ref. No. :FP0339/1001

Mfg. Date : May / 11

Date Sampled : 24.05.11 to 28.05.11 Date of Analysis : 24.05.11 to 30.05.11 Exp Date : May / 13

Tests Results

2 Identity Same Positive

6 Diameter 5.00 - 5.40 mm 5.21 - 5.23 mm

7 Hardness 1.00 - 5.00 kp 1.50 - 4.60 kp

8 Thickness 1.90 - 2.60 mm 2.03 - 2.16 mm

12 Assay 5.85 - 7.15 mg / tablet 6.74 mg/ tab

Released for use

Rejected

Product : Kalfree Tablet

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

[ Ref : BP ]

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.31 %KF

Remarks : Ok Reference : Book - 168 ; Page - 160.

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Oct /10

Date Sampled : 23.10.10 to 26.10.10 Date of Analysis : 23.10.10 to 02.11.10 Exp Date : Oct /12

Tests Results

1 Description White to off white RFBE Tablet White to off white RFBE Tablet

6 Diameter 5.00 - 5.40 mm 5.21 - 5.23 mm

7 Hardness 1.00 - 5.00 kp 1.60 - 4.80 kp

8 Thickness 1.90 - 2.60 mm 2.07 - 2.23 mm

9 Disintegration time NMT 15.00 minutes (BP) 30- 55 sec

11 Friability NMT 1.00 % (BP ) 0.48 - 0.84%

12 Assay 5.85 - 7.15 mg / tablet 6.29 mg

Released for use

Rejected

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.09 %KF

Remarks : Reference : B - 136 & P - 173

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Batch Size : 5000 Packs Analytical Ref. No. :FP0339/0002

Mfg. Date : Aug /10

Date Sampled : 25.08.10 to 27.08.10 Date of Analysis : 25.08.10 to 02.09.10 Exp Date : Aug /12

Tests Results

6 Diameter 5.00 - 5.40 mm 5.21 - 5.23 mm

7 Hardness 1.00 - 5.00 kp 2.40 - 5.00 kp

8 Thickness 1.90 - 2.60 mm 2.03 - 2.17 mm

Released for use

Rejected

Product : CAL X Tablet

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.35 %KF

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Batch Size : 5000 Packs Analytical Ref. No. :FP0339/0001

Mfg. Date : Aug /10

Tests Results

6 Diameter 5.00 - 5.40 mm 5.21 - 5.23 mm

7 Hardness 1.00 - 5.00 kp 2.40 - 5.00 kp

8 Thickness 1.90 - 2.60 mm 2.03 - 2.17 mm

Released for use

Rejected

Product : CAL X Tablet

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.35 %KF

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Feb /10

Date Sampled : 10.02.10 to 14.02.10 Date of Analysis : 10.02.10 to 14.02.10 Exp Date : Feb /12

Tests Results

5 Water / LOD

6 Diameter 5.00 - 5.40 mm 5.24 - 5.28 mm

7 Hardness 1.00 - 5.00 kp 1.70 - 4.50 kp

8 Thickness 1.90 - 2.60 mm 2.02 - 2.11 mm

Released for use

Rejected

Sl. No.

SK+F Specifications

NMT + 2.50 % of theoretical weight ( 58.00 -

62.00 mg )

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.23 %KF 2.21 % LOD

Remarks : OK Reference : B - 93 & P - 225

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Aug /10

Tests Results

6 Diameter 5.00 - 5.40 mm 5.21 - 5.23 mm

7 Hardness 1.00 - 5.00 kp 2.40 - 5.00 kp

8 Thickness 1.90 - 2.60 mm 2.03 - 2.17 mm

Released for use

Rejected

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.35 %KF

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Aug /10

Tests Results

6 Diameter 5.00 - 5.40 mm 5.20 - 5.23 mm

7 Hardness 1.00 - 5.00 kp 2.00 - 4.50 kp

8 Thickness 1.90 - 2.60 mm 2.07 - 2.17 mm

Released for use

Rejected

Sl. No.

SK+F Specifications

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

4.98 %KF

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Mar /10

Date Sampled : 10.04.10 to 15.04.10 Date of Analysis : 10.04.10 to 04.05.10 Exp Date : Mar /12

Tests Results

6 Diameter 5.00 - 5.40 mm 5.24 - 5.35 mm

7 Hardness 1.00 - 5.00 kp 1.70 - 4.50 kp

8 Thickness 1.90 - 2.60 mm 1.94 - 2.16 mm

11 Friability NMT 1.00 % (BP ) 0.56-0.68%

Released for use

Rejected

Sl. No.

SK+F Specifications

62.00 mg )

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.13 %KF

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Mar /10

Date Sampled : 10.04.10 to 15.04.10 Date of Analysis : 10.04.10 to 04.05.10 Exp Date : Mar /12

Tests Results

6 Diameter 5.00 - 5.40 mm 5.22 - 5.37 mm

7 Hardness 1.00 - 5.00 kp 1.70 - 3.90 kp

8 Thickness 1.90 - 2.60 mm 2.08 - 2.22 mm

10 Dissolving time with stirring NMT 90 sec 40-50 sec

11 Friability NMT 1.00 % (BP ) 0.59%

Released for use

Rejected

Sl. No.

SK+F Specifications

62.00 mg )

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

4.56 %KF

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Feb /10

Tests Results

5 Water / LOD

6 Diameter 5.00 - 5.40 mm 5.24 - 5.28 mm

7 Hardness 1.00 - 5.00 kp *2.90 - 5.90 kp

8 Thickness 1.90 - 2.60 mm 2.02 - 2.11 mm

Released for use

Rejected

Sl. No.

SK+F Specifications

62.00 mg )

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.23 %KF 2.21 % LOD

Remarks : *Out of specification . OOS/MFG1/10/0010,OOS report attachted. Reference : B - 93 & P - 225

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Mfg. Date : Feb /10

Tests Results

5 Water / LOD

6 Diameter 5.00 - 5.40 mm 5.22 - 5.42 mm

7 Hardness 1.00 - 5.00 kp *2.20 - 7.40 kp

8 Thickness 1.90 - 2.60 mm 1.98 - 2.08 mm

9 Disintegration time NMT 15.00 minutes (BP) 40.00 -45.00 sec

Released for use

Rejected

Sl. No.

SK+F Specifications

62.00 mg )

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

5.45 %KF 2.75 % LOD

Remarks : *Out of specification . OOS/MFG1/10/0010,OOS report attachted. Reference : B - 93 & P - 225

Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE

Batch Size : 500000 Tubes Analytical Ref. No. :FP0339/9004

Mfg. Date : Nov / 09

Date Sampled : 22.11.09 to 25.11.09 Date of Analysis : 22.11.09 to 10.01.10 Exp Date : Nov / 11

Tests Results

5 Water / LOD 4.97%

6 Diameter 5.00 - 5.40 mm 5.21 - 5.22 mm

7 Hardness 1.00 - 5.00 kp 2.20 - 4.70 kp

8 Thickness 1.90 - 2.60 mm 2.04 - 2.19 mm

9 Disintegration time NMT 15.00 minutes (BP) 35.00 - 50.00 sec

Released for use

Rejected

Sl. No.

SK+F Specifications

62.00 mg )

by more than ± 20% ( 48.00 - 72.00 )mg

3.50 - 6.50 % KF 1.50 - 3.50 % LOD

Remarks : OK. Reference : B - 93 & P - 194

Cal X Tablet (2004)

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