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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
mg )
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
2 Identity Same Complies
3 Average weight 60.71 mg
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
10 Dissolving time with stirring NMT 90 sec 60 - 75 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
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. :FP0427/2003
Batch No. : 2003 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
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% 5.05%
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
9 Disintegration time NMT 15.00 minutes (BP) 40 - 60 sec
10 Dissolving time with stirring NMT 90 sec 80 sec
11 Friability NMT 1.00 % (BP ) 0.06 - 0.13 %
12 Assay 5.85 - 7.15 mg / tablet 6.37 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
mg )
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 - 87
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0427/2001
Batch No. : 2001 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
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% 5.03%
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
9 Disintegration time NMT 15.00 minutes (BP) 45 - 55 sec
10 Dissolving time with stirring NMT 90 sec 45 sec
11 Friability NMT 1.00 % (BP ) 0.04 - 0.10 %
12 Assay 5.85 - 7.15 mg / tablet 6.39 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
mg )
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 -202 ; Page - 47
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0427/2002
Batch No. : 2002 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
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% 5.13%
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
9 Disintegration time NMT 15.00 minutes (BP) 35 - 58 sec
10 Dissolving time with stirring NMT 90 sec 90 sec
11 Friability NMT 1.00 % (BP ) 0.06 - 0.13 %
12 Assay 5.85 - 7.15 mg / tablet 6.42 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
mg )
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 -202 ; Page - 47
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
ESKAYEF BANGLADESH LIMITED400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur.
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
CERTIFICATE OF ANALYSIS PRODUCT
Product : Cal X Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 - 62.00
mg )
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 -
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
ESKAYEF BANGLADESH LIMITED400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur.
Phone : 0088-02-9802127-8, Fax : 0088-02-9801859
QUALITY ASSURANCE
Batch Size : 500,000 Tablet Analytical Ref. No. :FP0339/1001
Batch No. : 1001 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet Complies
2 Identity Same Positive
3 Average weight 60.00 mg
4 Uniformity of weight 58.00 - 62.00 mg
5 Water Cotent(KF) / LOD%
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
9 Disintegration time NMT 15.00 minutes (BP) 40 - 55 sec
10 Dissolving time with stirring NMT 90 sec 40 sec
11 Friability NMT 1.00 % (BP ) 0.74 - 0.91 %
12 Assay 5.85 - 7.15 mg / tablet 6.74 mg/ tab
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 - 62.00
mg )
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
5.31 %KF
Remarks : Ok Reference : Book - 168 ; Page - 160.
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0339/0007
Batch No. : 0007 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 58.00 - 62.00 mg
5 Water Cotent(KF) / LOD%
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
10 Dissolving time with stirring NMT 90 sec 40 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
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 - 62.00
mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
5.09 %KF
Remarks : Reference : B - 136 & P - 173
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
ESKAYEF BANGLADESH LIMITED400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur.
Phone : 0088-02-9802127-8, Fax : 0088-02-9801859
QUALITY ASSURANCE
Batch Size : 5000 Packs Analytical Ref. No. :FP0339/0002
Batch No. : 0002 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 58.00 - 62.00 mg
5 Water Cotent(KF) / LOD%
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
9 Disintegration time NMT 15.00 minutes (BP) 40 - 70 sec
10 Dissolving time with stirring NMT 90 sec 45 - 55 sec
11 Friability NMT 1.00 % (BP ) 0.73 - 0.92%
12 Assay 5.85 - 7.15 mg / tablet 6.27 mg
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
mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
5.35 %KF
Remarks : Reference : B - 124 & P - 231
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
ESKAYEF BANGLADESH LIMITED400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur.
Phone : 0088-02-9802127-8, Fax : 0088-02-9801859
QUALITY ASSURANCE
Batch Size : 5000 Packs Analytical Ref. No. :FP0339/0001
Batch No. : 0001 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 58.00 - 62.00 mg
5 Water Cotent(KF) / LOD%
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
9 Disintegration time NMT 15.00 minutes (BP) 40 - 70 sec
10 Dissolving time with stirring NMT 90 sec 45 - 55 sec
11 Friability NMT 1.00 % (BP ) 0.73 - 0.92%
12 Assay 5.85 - 7.15 mg / tablet 6.27 mg
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
mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
5.35 %KF
Remarks : Reference : B - 124 & P - 231
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0339/0002
Batch No. : 0002 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 57.00 - 63.00 mg
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
9 Disintegration time NMT 15.00 minutes (BP) 48 - 56 sec
10 Dissolving time with stirring NMT 90 sec 45 sec
11 Friability NMT 1.00 % (BP ) 0.26 - 0.56%
12 Assay 5.85 - 7.15 mg / tablet 6.39 mg
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 -
62.00 mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
5.23 %KF 2.21 % LOD
Remarks : OK Reference : B - 93 & P - 225
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0339/0005
Batch No. : 0005 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 58.00 - 62.00 mg
5 Water Cotent(KF) / LOD%
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
9 Disintegration time NMT 15.00 minutes (BP) 40 - 70 sec
10 Dissolving time with stirring NMT 90 sec 45 - 55 sec
11 Friability NMT 1.00 % (BP ) 0.73 - 0.92%
12 Assay 5.85 - 7.15 mg / tablet 6.27 mg
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 - 62.00
mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
5.35 %KF
Remarks : Reference : B - 124 & P - 231
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0339/0006
Batch No. : 0006 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 58.00 - 62.00 mg
5 Water Cotent(KF) / LOD%
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
9 Disintegration time NMT 15.00 minutes (BP) 40 - 60 sec
10 Dissolving time with stirring NMT 90 sec 50 - 60 sec
11 Friability NMT 1.00 % (BP ) 0.48 - 0.96%
12 Assay 5.85 - 7.15 mg / tablet 6.13 mg
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 - 62.00
mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
4.98 %KF
Remarks : Reference : B - 124 & P - 231
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0339/0004
Batch No. : 0004 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 57.00 - 63.00 mg
5 Water Cotent(KF) / LOD%
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
9 Disintegration time NMT 15.00 minutes (BP) 45 - 60 sec
10 Dissolving time with stirring NMT 90 sec 50 sec
11 Friability NMT 1.00 % (BP ) 0.56-0.68%
12 Assay 5.85 - 7.15 mg / tablet 6.43 mg
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 -
62.00 mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
5.13 %KF
Remarks : Reference : B - 124 & P - 74
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0339/0003
Batch No. : 0003 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 58.00 - 62.00 mg
5 Water Cotent(KF) / LOD%
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
9 Disintegration time NMT 15.00 minutes (BP) 35 - 50 sec
10 Dissolving time with stirring NMT 90 sec 40-50 sec
11 Friability NMT 1.00 % (BP ) 0.59%
12 Assay 5.85 - 7.15 mg / tablet 6.74 mg
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 -
62.00 mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
4.56 %KF
Remarks : Reference : B - 124 & P - 74
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0339/0002
Batch No. : 0002 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 57.00 - 63.00 mg
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
9 Disintegration time NMT 15.00 minutes (BP) 48 - 56 sec
10 Dissolving time with stirring NMT 90 sec 45 sec
11 Friability NMT 1.00 % (BP ) 0.26 - 0.56%
12 Assay 5.85 - 7.15 mg / tablet 6.39 mg
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 -
62.00 mg )
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
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
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
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. :FP0339/0001
Batch No. : 0001 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
Mfg. Date : Feb /10
Date Sampled : 09.02.10 to 13.02.10 Date of Analysis : 09.02.10 to 14.02.10 Exp Date : Feb /12
Tests Results
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 58.00 - 63.00 mg
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
10 Dissolving time with stirring NMT 90 sec 50 sec
11 Friability NMT 1.00 % (BP ) 0.44 - 0.56 %
12 Assay 5.85 - 7.15 mg / tablet 6.57 mg
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 -
62.00 mg )
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
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
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
ESKAYEF BANGLADESH LIMITED400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur.
Phone : 0088-02-9802127-8, Fax : 0088-02-9801859
QUALITY ASSURANCE
Batch Size : 500000 Tubes Analytical Ref. No. :FP0339/9004
Batch No. : 9004 Label claim : Sucralose NF 6.5 mg/ tablet Overage : X
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
1 Description White to off white RFBE Tablet White to off white RFBE Tablet
2 Identity Same Complies
3 Average weight 60.00 mg
4 Uniformity of weight 59.00 - 62.00 mg
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
10 Dissolving time with stirring NMT 90 sec 30 sec
11 Friability NMT 1.00 % (BP ) 0.52 - 0.73 %
12 Assay 5.85 - 7.15 mg / tablet 6.45 mg
Released for use
Rejected
CERTIFICATE OF ANALYSIS PRODUCT
Product : Kalfree Tablet
Sl. No.
SK+F Specifications
NMT + 2.50 % of theoretical weight ( 58.00 -
62.00 mg )
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
3.50 - 6.50 % KF 1.50 - 3.50 % LOD
Remarks : OK. Reference : B - 93 & P - 194
Prepared by QC Officer/Sr. QC Officer
Checked by QC Officer/Sr. QC Officer
Approved by QC Manager
