ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Cal X Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0427/2005 Batch No. Mfg. Date : 2005 : May 12 : May /14

Date Sampled : 26.05.12 to 28.05.12

Date of Analysis : 26.05.12 to 04.06.12

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results Complies Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.35% 5.20 - 5.21 mm 2.80 - 4.60 Kp 2.12 - 2.27 mm 60 - 85 sec 40 - 45 sec 0.07 - 0.08 %

12

Assay

5.85 - 7.15 mg / tablet

6.36 mg tab

Remarks : Ok Reference : Book -219 ; Page - 151 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

CERTIFICATE OF ANALYSIS
Product Name Label claim Sample SIze Batch No. Mfg. Date Exp. Date Date of Analysis
Sl. No. 1 2 3 Description Identity Average weight

: Cal X Tablet : Sucralose NF 6.5 mg / tablet : 300 Tablets : 2004 : April 12 : April 14 : 28.06.12 to 30.06.12

Tests

Specifications White to off white RFBE Tablet Same Theoretical weight 2.50% (58.00 - 62.00) mg

Results Complies Complies 60.71 mg

Uniformity of weight

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)

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

KF: (3.50 - 6.50)% LOD: (1.50 - 3.50)% 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes NMT 90 sec NMT 1.00%

KF: 5.70% 5.20 - 5.22 mm 3.10 - 3.50 kp 2.21 - 2.23 mm 40 - 60 sec 60 - 75 sec 0.18 - 0.22 %

12

Assay

5.85 - 7.15 mg / tablet

6.34 mg / tablet

Remarks

: OK

Prepared by Lecturer Dept. of Pharmaceutical Technology

Checked by Lecturer Dept. of Pharmaceutical Technology

Approved by Chairman Dept. of Pharmaceutical Technology

Results Complies Complies 60.71 mg

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

KF: 5.70% 5.20 - 5.22 mm 3.10 - 3.50 kp 2.21 - 2.23 mm 40 - 60 sec 60 - 75 sec 0.18 - 0.22 %

6.34 mg / tablet

Approved by Chairman Dept. of Pharmaceutical Technology

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Cal X Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0427/2003 Batch No. Mfg. Date : 2003 : Apr /12 : Apr /14

Date Sampled : 26.04.12 to 29.04.12

Date of Analysis : 26.04.12 to 07.05.12

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results Complies Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.05% 5.20 - 5.22 mm 2.80 - 4.10 Kp 2.18 - 2.24 mm 40 - 60 sec 80 sec 0.06 - 0.13 %

12

Assay

5.85 - 7.15 mg / tablet

6.37 mg tab

Remarks : Ok Reference : Book -219 ; Page - 87 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Cal X Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0427/2001 Batch No. Mfg. Date : 2001 : Jan /12 : Jan /14

Date Sampled : 16.01.12 to 17.01.12

Date of Analysis : 17.01.12 to 18.01.12

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results Complies Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.03% 5.20 - 5.21 mm 2.70 - 4.10 Kp 2.20 - 2.28 mm 45 - 55 sec 45 sec 0.04 - 0.10 %

12

Assay

5.85 - 7.15 mg / tablet

6.39 mg tab

Remarks : Ok Reference : Book -202 ; Page - 47 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Cal X Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0427/2002 Batch No. Mfg. Date : 2002 : Jan /12 : Jan /14

Date Sampled : 16.01.12 to 17.01.12

Date of Analysis : 16.01.12 to 18.01.12

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results Complies Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.13% 5.20 - 5.21 mm 2.40 - 4.40 Kp 2.20 - 2.28 mm 35 - 58 sec 90 sec 0.06 - 0.13 %

12

Assay

5.85 - 7.15 mg / tablet

6.42 mg tab

Remarks : Ok Reference : Book -202 ; Page - 47 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Cal X Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: Tablet :X

Analytical Ref. No. :FP0427/ Batch No. Mfg. Date : : :

Date Sampled :

Date of Analysis :

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results

Average weight

Uniformity of weight

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

12

Assay

5.85 - 7.15 mg / tablet

Remarks : Ok Reference : Book - ; Page Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500,000 Tablet :X

Analytical Ref. No. :FP0339/1001 Batch No. Mfg. Date : 1001 : May / 11 : May / 13

Date Sampled : 24.05.11 to 28.05.11

Date of Analysis : 24.05.11 to 30.05.11

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results Complies Positive 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.31 %KF 5.21 - 5.23 mm 1.50 - 4.60 kp 2.03 - 2.16 mm 40 - 55 sec 40 sec 0.74 - 0.91 %

12

Assay

5.85 - 7.15 mg / tablet

6.74 mg/ tab

Remarks : Ok Reference : Book - 168 ; Page - 160. Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0339/0007 Batch No. Mfg. Date : 0007 : Oct /10 : Oct /12

Date Sampled : 23.10.10 to 26.10.10

Date of Analysis : 23.10.10 to 02.11.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.09 %KF 5.21 - 5.23 mm 1.60 - 4.80 kp 2.07 - 2.23 mm 30- 55 sec 40 sec 0.48 - 0.84%

12

Assay

5.85 - 7.15 mg / tablet

6.29 mg

Remarks : Reference : B - 136 & P - 173 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: CAL X Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 5000 Packs :X

Analytical Ref. No. :FP0339/0002 Batch No. Mfg. Date : 0002 : Aug /10 : Aug /12

Date Sampled : 25.08.10 to 27.08.10 Sl. No. 1 2 3 Description Identity Average weight

Date of Analysis : 25.08.10 to 02.09.10 SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Exp Date

Tests

Results White to off white RFBE Tablet Complies 60.00 mg

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.35 %KF 5.21 - 5.23 mm 2.40 - 5.00 kp 2.03 - 2.17 mm 40 - 70 sec 45 - 55 sec 0.73 - 0.92%

12

Assay

5.85 - 7.15 mg / tablet

6.27 mg

Remarks : Reference : B - 124 & P - 231 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: CAL X Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 5000 Packs :X

Analytical Ref. No. :FP0339/0001 Batch No. Mfg. Date : 0001 : Aug /10 : Aug /12

Date Sampled : 25.08.10 to 27.08.10 Sl. No. 1 2 3 Description Identity Average weight

Date of Analysis : 25.08.10 to 02.09.10 SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Exp Date

Tests

Results White to off white RFBE Tablet Complies 60.00 mg

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.35 %KF 5.21 - 5.23 mm 2.40 - 5.00 kp 2.03 - 2.17 mm 40 - 70 sec 45 - 55 sec 0.73 - 0.92%

12

Assay

5.85 - 7.15 mg / tablet

6.27 mg

Remarks : Reference : B - 124 & P - 231 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0339/0002 Batch No. Mfg. Date : 0002 : Feb /10 : Feb /12

Date Sampled : 10.02.10 to 14.02.10

Date of Analysis : 10.02.10 to 14.02.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

57.00 - 63.00 mg

5 6 7 8 9 10 11

Water / LOD Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.23 %KF 2.21 % LOD 5.24 - 5.28 mm 1.70 - 4.50 kp 2.02 - 2.11 mm 48 - 56 sec 45 sec 0.26 - 0.56%

12

Assay

5.85 - 7.15 mg / tablet

6.39 mg

Remarks : OK Reference : B - 93 & P - 225 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0339/0005 Batch No. Mfg. Date : 0005 : Aug /10 : Aug /12

Date Sampled : 25.08.10 to 27.08.10

Date of Analysis : 25.08.10 to 02.09.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.35 %KF 5.21 - 5.23 mm 2.40 - 5.00 kp 2.03 - 2.17 mm 40 - 70 sec 45 - 55 sec 0.73 - 0.92%

12

Assay

5.85 - 7.15 mg / tablet

6.27 mg

Remarks : Reference : B - 124 & P - 231 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0339/0006 Batch No. Mfg. Date : 0006 : Aug /10 : Aug /12

Date Sampled : 25.08.10 to 27.08.10

Date of Analysis : 25.08.10 to 02.09.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

4.98 %KF 5.20 - 5.23 mm 2.00 - 4.50 kp 2.07 - 2.17 mm 40 - 60 sec 50 - 60 sec 0.48 - 0.96%

12

Assay

5.85 - 7.15 mg / tablet

6.13 mg

Remarks : Reference : B - 124 & P - 231 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0339/0004 Batch No. Mfg. Date : 0004 : Mar /10 : Mar /12

Date Sampled : 10.04.10 to 15.04.10

Date of Analysis : 10.04.10 to 04.05.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

57.00 - 63.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.13 %KF 5.24 - 5.35 mm 1.70 - 4.50 kp 1.94 - 2.16 mm 45 - 60 sec 50 sec 0.56-0.68%

12

Assay

5.85 - 7.15 mg / tablet

6.43 mg

Remarks : Reference : B - 124 & P - 74 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0339/0003 Batch No. Mfg. Date : 0003 : Mar /10 : Mar /12

Date Sampled : 10.04.10 to 15.04.10

Date of Analysis : 10.04.10 to 04.05.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 62.00 mg

5 6 7 8 9 10 11

Water Cotent(KF) / LOD% Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

4.56 %KF 5.22 - 5.37 mm 1.70 - 3.90 kp 2.08 - 2.22 mm 35 - 50 sec 40-50 sec 0.59%

12

Assay

5.85 - 7.15 mg / tablet

6.74 mg

Remarks : Reference : B - 124 & P - 74 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0339/0002 Batch No. Mfg. Date : 0002 : Feb /10 : Feb /12

Date Sampled : 10.02.10 to 14.02.10

Date of Analysis : 10.02.10 to 14.02.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

57.00 - 63.00 mg

5 6 7 8 9 10 11

Water / LOD Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.23 %KF 2.21 % LOD 5.24 - 5.28 mm *2.90 - 5.90 kp 2.02 - 2.11 mm 48 - 56 sec 45 sec 0.26 - 0.56%

12

Assay

5.85 - 7.15 mg / tablet

6.39 mg

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

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tablet :X

Analytical Ref. No. :FP0339/0001 Batch No. Mfg. Date : 0001 : Feb /10 : Feb /12

Date Sampled : 09.02.10 to 13.02.10

Date of Analysis : 09.02.10 to 14.02.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

58.00 - 63.00 mg

5 6 7 8 9 10 11

Water / LOD Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

5.45 %KF 2.75 % LOD 5.22 - 5.42 mm *2.20 - 7.40 kp 1.98 - 2.08 mm 40.00 -45.00 sec 50 sec 0.44 - 0.56 %

12

Assay

5.85 - 7.15 mg / tablet

6.57 mg

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

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager

ESKAYEF BANGLADESH LIMITED

400 Tongi Industrial Area, Squibb Road, Tongi, Gazipur. Phone : 0088-02-9802127-8, Fax : 0088-02-9801859

QUALITY ASSURANCE
CERTIFICATE OF ANALYSIS
PRODUCT

Product
Label claim

: Kalfree Tablet
: Sucralose NF 6.5 mg/ tablet

Batch Size Overage

: 500000 Tubes :X

Analytical Ref. No. :FP0339/9004 Batch No. Mfg. Date : 9004 : Nov / 09 : Nov / 11

Date Sampled : 22.11.09 to 25.11.09

Date of Analysis : 22.11.09 to 10.01.10

Exp Date

Sl. No. 1 2 3 Description Identity

Tests

SK+F Specifications White to off white RFBE Tablet Same 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 5.00 - 5.40 mm 1.00 - 5.00 kp 1.90 - 2.60 mm NMT 15.00 minutes (BP) NMT 90 sec NMT 1.00 % (BP )

Results White to off white RFBE Tablet Complies 60.00 mg

Average weight

Uniformity of weight

59.00 - 62.00 mg

5 6 7 8 9 10 11

Water / LOD Diameter Hardness Thickness Disintegration time Dissolving time with stirring Friability

4.97% 5.21 - 5.22 mm 2.20 - 4.70 kp 2.04 - 2.19 mm 35.00 - 50.00 sec 30 sec 0.52 - 0.73 %

12

Assay

5.85 - 7.15 mg / tablet

6.45 mg

Remarks : OK. Reference : B - 93 & P - 194 Released for use Rejected

Prepared by QC Officer/Sr. QC Officer

Checked by QC Officer/Sr. QC Officer

Approved by QC Manager