Gut No.11/12/14/15, Paithan Road,

T +91 2431 6650 00

Chitegaon,

F +91 2431 6650 13

Aurangabad-431 105

E info@ajantapharma.com

Maharashtra-INDIA

W www.ajantapharma.com

CERTIFICATE OF ANALYSIS -FINISHED PRODUCTNAME OF THE SAMPLE

KAMAGRA CHEWABLE TABLETS 100 mg (Sildenafil Chewable Tablets 100 mg)

PRODUCT CODE

5000562

INSPECTION LOT NO.

40000052732

BATCH NO.

CT0310F

BATCH SIZE

100000 BL

MFG. DATE

06.2020

EXP. DATE

05.2023

SAMPLED BY

Pravin Kocheta

SAMPLING DATE

17.06.2020

SAMPLED QTY.

120 BLRELEASED DATE

27.06.2020PROCESS ORDER NO.

10038255

PACK SIZE

1X4'S

Note : [a] for Abbreviations. Detail provided in Abbreviation section.
SR.NO.

TESTaOrange Flavour

1.0

Description

SPECIFICATIONRESULT

Light orange to orange coloured, diamond shaped,

Light orange coloured, diamond shaped, uncoated,uncoated, chewable tablets, engraved with ‘ap’ logo on

chewable tablets, engraved with ‘ap’ logo on one

one side and ‘KGR 100’ on the other side and with slightside and ‘KGR 100’ on the other side and withmottled appearance.

slight mottled appearance.
Complies

2.0

Identification2.1

Sildenafil

The retention time of the major peak in the chromatogram The retention time of the major peak in theof the sample preparation corresponds to that of the peakchromatogram of the sample preparation

due to Sildenafil in the chromatogram of the standard

corresponds to that of the peak due to Sildenafil

preparation, as obtained in the assay.

in the chromatogram of the standard preparation,
as obtained in the assay.
Complies

3.0

Average weight600.6 mg ± 5.0%

597.800 mg

4.0

Uniformity of weightNot more than 2 of the individual weights deviate from

Min = 595.6 mg, Max = 601.7 mg

the average weight by more than ± 5% and none deviates by Avg = 597.99 mg
more than ± 10%

Complies
Not Detected

5.0

Related substances

5.1

Individual impurity

Not more than 1.0%

5.2

Total impurities [a]Not more than 2.0%

6.0

Assay

6.1

Sildenafil Citrate IP

Not less than 90.0% and not more than 110.0% of theEQV to Sildenafil [a]labeled claim.

0.00 %
Not Detected
0.00 %bPineapple Flavour

1.0Description

Light yellow to yellow coloured, diamond shaped,99.60 %Light yellow to yellow coloured, diamond shaped,

Remark: A - Release (Domestic- Deemed Export)
Comment: The sample submitted Complies with the prescribed Finished product specification FPS/16-17/0343 Version: 01.
Analysed By

Vandana Ahire

Checked By Swati Dhoke

Approved By Sudhir Deshpande

Designation

Sr. Officer

Designation Asst. Manager

Designation Deputy Manager

Date

27.06.2020

Date

Date

Printed By : Pravin Kocheta

27.06.2020

Printed On : 27.06.2020

13:50:29

Note : This document has been generated electronically and is valid without signature
Format No. CQA/F/160,Version:01
Regd./Corp. Office : Ajanta House, Charkop, Kandivali(W),Mumbai-400 067. Tel.: +91- 22-6606 1000 Fax: +91- 22-6606 1200

27.06.2020

Page No.: 1 of 4
Copy No.

1Reference SOP No. SOP/CQA/089
Corporate Identity Number - L24230MH1979PLC022059

Gut No.11/12/14/15, Paithan Road,

T +91 2431 6650 00

Chitegaon,

F +91 2431 6650 13

Aurangabad-431 105

E info@ajantapharma.com

Maharashtra-INDIA

W www.ajantapharma.com

CERTIFICATE OF ANALYSIS -FINISHED PRODUCTNAME OF THE SAMPLE

KAMAGRA CHEWABLE TABLETS 100 mg (Sildenafil Chewable Tablets 100 mg)

PRODUCT CODE

5000562

INSPECTION LOT NO.

40000052732

BATCH NO.

CT0310F

BATCH SIZE

100000 BL

MFG. DATE

06.2020

EXP. DATE

05.2023

SAMPLED BY

Pravin Kocheta

SAMPLING DATE

17.06.2020

SAMPLED QTY.

120 BLRELEASED DATE

27.06.2020

PROCESS ORDER NO.

10038255

PACK SIZE

1X4'S

SR.NO.

TEST

SPECIFICATIONRESULT

uncoated, chewable tablets, engraved with ‘ap’ logo on

uncoated, chewable tablets, engraved with ‘ap’

one side and ‘KGR 100’ on the other side and with slightlogo on one side and ‘KGR 100’ on the other side

mottled appearance.

and with slight mottled appearance.
Complies

2.0

Identification

2.1

Sildenafil

The retention time of the major peak in the chromatogram The retention time of the major peak in theof the sample preparation corresponds to that of the peakchromatogram of the sample preparation

due to Sildenafil in the chromatogram of the standard

corresponds to that of the peak due to Sildenafil

preparation, as obtained in the assay.

in the chromatogram of the standard preparation,
as obtained in the assay.
Complies

3.0Average weight600.6 mg ± 5.0%

597.520 mg

4.0

Uniformity of weightNot more than 2 of the individual weights deviate from

Min = 594.7 mg, Max = 599.2 mg

the average weight by more than ± 5% and none deviates by Avg = 597.29 mg
more than ± 10%.

Complies

5.0

Related substances

5.1

Individual impurity

Not more than 1.0%

0.33 %

5.2

Total impurities [a]Not more than 2.0%

0.33 %

6.0

Assay

6.1

Sildenafil Citrate IP

Not less than 90.0% and not more than 110.0% of labeled

99.20 %

EQV to Sildenafil [a]claim.

cStrawberry Flavour

1.0Description

Light pink to pink coloured, diamond shaped, uncoatedLight pink coloured, diamond shaped, uncoatedchewable tablets, engraved with ‘ap’ logo on one side andchewable tablets, engraved with ‘ap’ logo on one‘KGR 100’ on the other side and with slight mottled

side and ‘KGR 100’ on the other side and withappearance.

slight mottled appearance.
Complies

2.0

Identification

Remark: A - Release (Domestic- Deemed Export)
Comment: The sample submitted Complies with the prescribed Finished product specification FPS/16-17/0343 Version: 01.
Analysed By

Vandana Ahire

Checked By Swati Dhoke

Approved By Sudhir Deshpande

Designation

Sr. Officer

Designation Asst. Manager

Designation Deputy Manager

Date

27.06.2020

DateDate

Printed By : Pravin Kocheta

27.06.2020

Printed On : 27.06.2020

13:50:29

Note : This document has been generated electronically and is valid without signature
Format No. CQA/F/160,Version:01
Regd./Corp. Office : Ajanta House, Charkop, Kandivali(W),Mumbai-400 067. Tel.: +91- 22-6606 1000 Fax: +91- 22-6606 1200

27.06.2020

Page No.: 2 of 4Copy No.

1

Reference SOP No. SOP/CQA/089
Corporate Identity Number - L24230MH1979PLC022059

Gut No.11/12/14/15, Paithan Road,

T +91 2431 6650 00

Chitegaon,

F +91 2431 6650 13

Aurangabad-431 105

E info@ajantapharma.com

Maharashtra-INDIA

W www.ajantapharma.com

CERTIFICATE OF ANALYSIS -FINISHED PRODUCTNAME OF THE SAMPLE

KAMAGRA CHEWABLE TABLETS 100 mg (Sildenafil Chewable Tablets 100 mg)

PRODUCT CODE

5000562

INSPECTION LOT NO.

40000052732

BATCH NO.

CT0310F

BATCH SIZE

100000 BL

MFG. DATE

06.2020

EXP. DATE

05.2023

SAMPLED BY

Pravin Kocheta

SAMPLING DATE

17.06.2020

SAMPLED QTY.

120 BLRELEASED DATE

27.06.2020

PROCESS ORDER NO.

10038255

PACK SIZE

1X4'S

SR.NO.
2.1

TEST
Sildenafil

SPECIFICATIONRESULTThe retention time of the major peak in the chromatogram The retention time of the major peak in theof the sample preparation corresponds to that of the peakchromatogram of the sample preparation

due to Sildenafil in the chromatogram of the standard

corresponds to that of the peak due to Sildenafil

preparation, as obtained in the assay.

in the chromatogram of the standard preparation,
as obtained in the assay.
Complies

3.0

Average weight600.6 mg ± 5.0%

597.980 mg

4.0

Uniformity of weightNot more than 2 of the individual weights deviate from

Min = 595.3 mg, Max = 602.1 mg

the average weight by more than ± 5% and none deviates by Avg = 598.15 mg
more than ± 10%

Complies

5.0

Related substances

5.1

Individual impurity

Not more than 1.0%

0.25 %

5.2

Total impurities [a]Not more than 2.0%

0.25 %

6.0Assay

6.1

Sildenafil Citrate IP

Not less than 90.0% and not more than 110.0% of labeled

97.70 %

EQV to Sildenafil [a]claim.

dBanana Flavour

1.0

Description

Pale yellow to yellow coloured, diamond shaped, uncoated, Pale yellow coloured, diamond shaped, uncoated,chewable tablets, engraved with ‘ap’ logo on one side andchewable tablets, engraved with ‘ap’ logo on one‘KGR 100’ on the other side.

side and ‘KGR 100’ on the other side.
Complies

2.0

Identification

2.1

Sildenafil

The retention time of the major peak in the chromatogram The retention time of the major peak in theof the sample preparation corresponds to that of the peakchromatogram of the sample preparation

due to Sildenafil in the chromatogram of the standard

corresponds to that of the peak due to Sildenafil

preparation, as obtained in the assay.

in the chromatogram of the standard preparation,
as obtained in the assay.
Complies

Remark: A - Release (Domestic- Deemed Export)
Comment: The sample submitted Complies with the prescribed Finished product specification FPS/16-17/0343 Version: 01.
Analysed By

Vandana Ahire

Checked By Swati Dhoke

Approved By Sudhir Deshpande

Designation

Sr. Officer

Designation Asst. Manager

Designation Deputy Manager

Date

27.06.2020

DateDate

Printed By : Pravin Kocheta

27.06.2020

Printed On : 27.06.2020

13:50:29

Note : This document has been generated electronically and is valid without signature
Format No. CQA/F/160,Version:01
Regd./Corp. Office : Ajanta House, Charkop, Kandivali(W),Mumbai-400 067. Tel.: +91- 22-6606 1000 Fax: +91- 22-6606 1200

27.06.2020

Page No.: 3 of 4
Copy No.

1Reference SOP No. SOP/CQA/089
Corporate Identity Number - L24230MH1979PLC022059

Gut No.11/12/14/15, Paithan Road,

T +91 2431 6650 00

Chitegaon,

F +91 2431 6650 13

Aurangabad-431 105

E info@ajantapharma.com

Maharashtra-INDIA

W www.ajantapharma.com

CERTIFICATE OF ANALYSIS -FINISHED PRODUCTNAME OF THE SAMPLE

KAMAGRA CHEWABLE TABLETS 100 mg (Sildenafil Chewable Tablets 100 mg)

PRODUCT CODE

5000562

INSPECTION LOT NO.

40000052732

BATCH NO.

CT0310F

BATCH SIZE

100000 BL

MFG. DATE

06.2020

EXP. DATE

05.2023

SAMPLED BY

Pravin Kocheta

SAMPLING DATE

17.06.2020

SAMPLED QTY.

120 BLRELEASED DATE

27.06.2020PROCESS ORDER NO.

10038255

PACK SIZE

1X4'S

SR.NO.

TEST

SPECIFICATIONRESULT

3.0

Average weight600.6 mg ± 5.0%

598.910 mg

4.0

Uniformity of weightNot more than 2 of the individual weights deviate from

Min = 596.4 mg, Max = 603.9 mg

the average weight by more than ± 5% and none deviates by Avg = 599.98 mg
more than ± 10%

Complies

5.0

Related substances

5.1

Individual impurity

Not more than 1.0%

0.10 %

5.2

Total impurities [a]Not more than 2.0%

0.10 %

6.0

Assay

6.1

Sildenafil Citrate IP

Not less than 90.0% and not more than 110.0% of labeled

97.80 %

EQV to Sildenafil [a]claim.

Section : [a] Abbreviation
Total impurities [a]: Total impurities (Sum of all specified and unspecified impurities).
Sildenafil Citrate IP EQV to Sildenafil [a]: Sildenafil Citrate equivalent to Sildenafil.
Total impurities [a]: Total impurities (Sum of all specified and unspecified impurities).
Sildenafil Citrate IP EQV to Sildenafil [a]: Sildenafil Citrate equivalent to Sildenafil.
Total impurities [a]: Total impurities (Sum of all specified and unspecified impurities).
Sildenafil Citrate IP EQV to Sildenafil [a]: Sildenafil Citrate equivalent to Sildenafil.
Total impurities [a]: Total impurities (Sum of all specified and unspecified impurities).
Sildenafil Citrate IP EQV to Sildenafil [a]: Sildenafil Citrate equivalent to Sildenafil.

Remark: A - Release (Domestic- Deemed Export)
Comment: The sample submitted Complies with the prescribed Finished product specification FPS/16-17/0343 Version: 01.
Analysed By

Vandana Ahire

Checked By Swati Dhoke

Approved By Sudhir Deshpande

Designation

Sr. Officer

Designation Asst. Manager

Designation Deputy ManagerDate

27.06.2020

DateDate

Printed By : Pravin Kocheta

27.06.2020

Printed On : 27.06.2020

13:50:29

Note : This document has been generated electronically and is valid without signature
Format No. CQA/F/160,Version:01
Regd./Corp. Office : Ajanta House, Charkop, Kandivali(W),Mumbai-400 067. Tel.: +91- 22-6606 1000 Fax: +91- 22-6606 1200

27.06.2020

Page No.: 4 of 4Copy No.

1Reference SOP No. SOP/CQA/089
Corporate Identity Number - L24230MH1979PLC022059