STABLITY STUDIES - FP

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 STABILITY PROTOCOL
INDEX

S.
CONTENTS PAGE NO
NO.
i Approval page 3

1 Purpose 4

2 Test Design 4
2.1 Test Material 4
2.2 Testing Plan 4

3 Number of samples 5

3.1 Accelerated stability studies 5

3.2 Real Time stability studies 6

4 Report content 6

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 STABILITY REPORT
INDEX

S.
CONTENTS PAGE NO
NO.
i Approval page 3

1 Responsibility 5

2 Summary 5
3 Objective 5
4 Test Material 5

5 Composition 6

6 Packaging 7

7 Storage conditions and testing intervals 7

8 Analytical procedures 7

9 Reference standard 7

10 Results 7

11 Discussion / Conclusions 8

12 Test results in tabular form 8

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STABLITY STUDIES - API

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 TABLE I: ACCELERATED STABILITY STUDY REPORT
PRODUCT NAME: Amoxicillin Trihydrate BP MFG.Date: 04/2012
STORAGE CONDITIONS:400c±20 c&RH75%±5% EXP.Date: 03/2016
BATCH.NO: ST/CPT/001 SHELF LIFE:4 year
BATCH SIZE: 100.0 Kg DATE STARTED:10/04/2012
REFERENCE:ICH DATE COMPLETED:10/10/2012

Results
Test Specification
Initial 1st Month 2nd Month 3rd Month 6th Month
A white or almost white, crystalline White crystalline White crystalline White crystalline White crystalline White crystalline
Characters
powder. powder powder powder powder powder
Slightly soluble in Slightly soluble in Slightly soluble in Slightly soluble in Slightly soluble in
water, very water, very water, very water, very water, very
Slightly soluble in water, very slightly slightly soluble in slightly soluble in slightly soluble in slightly soluble in slightly soluble in
soluble in ethanol (96 per cent), practically ethanol (96 per ethanol (96 per ethanol (96 per ethanol (96 per ethanol (96 per
cent), practically cent), practically cent), practically cent), practically cent), practically
Solubility insoluble in fatty oils. It dissolves in dilute
insoluble in fatty insoluble in fatty insoluble in fatty insoluble in fatty insoluble in fatty
acids and dilute solutions of alkali oils. It dissolves in oils. It dissolves in oils. It dissolves in oils. It dissolves in oils. It dissolves in
hydroxides. dilute acids and dilute acids and dilute acids and dilute acids and dilute acids and
dilute solutions of dilute solutions of dilute solutions of dilute solutions of dilute solutions of
alkali hydroxides. alkali hydroxides. alkali hydroxides. alkali hydroxides. alkali hydroxides.
Identification
By Infrared Test IR spectrum should be match with Positive for Positive for Positive for Positive for Positive for
Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin
Spectrophotometry standard IR spectrum
Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate
pH 3.5 to 5.5 4.5 4.5 4.6 4.6 4.7
Specific optical
+ 290° to + 315° (anhydrous substance) + 296° + 296° + 296° + 297° + 298°
rotation
Related substances
Any impurity Not more than 1.0 per cent 0.3 % 0.3 % 0.4 % 0.4 % 0.5 %
N,N-Dimethylaniline Not more than 20 ppm 9 ppm 9 ppm 9 ppm 10 ppm 10 ppm
Water 11.5 % to 14.5 % 12.4 % 12.4 % 12.5 % 12.5 % 12.6 %
Sulfated ash Not more than 1.0% 0.4 % 0.4 % 0.5 % 0.5 % 0.6 %
Assay (in %) 95.0 per cent to 102.0 per cent 99.83 99.71 99.48 99.36 99.13

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Remarks: The above mention substance under the conditions mention above is stable up to the period of 6 months.

ANALYSED BY: APPROVEDBY:

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Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, India
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 TABLE II: ACCELERATED STABILITY STUDY REPORT
PRODUCT NAME: Amoxicillin Trihydrate BP MFG.Date: 04/2012
STORAGE CONDITIONS:400c±20 c&RH75%±5% EXP.Date: 03/2016
BATCH.NO: ST/CPT/002 SHELF LIFE:4 year
BATCH SIZE: 97.0 Kg DATE STARTED:15/04/2012
REFERENCE:ICH DATE COMPLETED:15/10/2012

Results
Test Specification
Initial 1st Month 2nd Month 3rd Month 6th Month
A white or almost white, crystalline White crystalline White crystalline White crystalline White crystalline White crystalline
Characters
powder. powder powder powder powder powder
Slightly soluble in Slightly soluble in Slightly soluble in Slightly soluble in Slightly soluble in
water, very water, very water, very water, very water, very
Slightly soluble in water, very slightly slightly soluble in slightly soluble in slightly soluble in slightly soluble in slightly soluble in
soluble in ethanol (96 per cent), practically ethanol (96 per ethanol (96 per ethanol (96 per ethanol (96 per ethanol (96 per
cent), practically cent), practically cent), practically cent), practically cent), practically
Solubility insoluble in fatty oils. It dissolves in dilute
insoluble in fatty insoluble in fatty insoluble in fatty insoluble in fatty insoluble in fatty
acids and dilute solutions of alkali oils. It dissolves in oils. It dissolves in oils. It dissolves in oils. It dissolves in oils. It dissolves in
hydroxides. dilute acids and dilute acids and dilute acids and dilute acids and dilute acids and
dilute solutions of dilute solutions of dilute solutions of dilute solutions of dilute solutions of
alkali hydroxides. alkali hydroxides. alkali hydroxides. alkali hydroxides. alkali hydroxides.
Identification
By Infrared Test IR spectrum should be match with Positive for Positive for Positive for Positive for Positive for
Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin
Spectrophotometry standard IR spectrum
Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate
pH 3.5 to 5.5 4.6 4.7 4.7 8.8 8.8
Specific optical
+ 290° to + 315° (anhydrous substance) + 95° + 296° + 296° + 297° + 297°
rotation
Related substances
Any impurity Not more than 1.0 per cent 0.3 % 0.3 % 0.3 % 0.4 % 0.4 %
N,N-Dimethylaniline Not more than 20 ppm 9 ppm 9 ppm 10 ppm 10 ppm 10 ppm
Water 11.5 % to 14.5 % 12.4 % 12.4 % 12.5 % 12.6 % 12.6 %
Sulfated ash Not more than 1.0% 0.3 % 0.4 % 0.3 % 0.5 % 0.6 %
Assay (in %) 95.0 per cent to 102.0 per cent 99.77 99.65 99.42 99.30 99.07

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Remarks: The above mention substance under the conditions mention above is stable up to the period of 6 months.

ANALYSED BY: APPROVEDBY:

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Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, India
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 TABLE III: ACCELERATED STABILITY STUDY REPORT
PRODUCT NAME: Amoxicillin Trihydrate BP MFG.Date: 04/2012
STORAGE CONDITIONS:400c±20 c&RH75%±5% EXP.Date: 03/2016
BATCH.NO: ST/CPT/003 SHELF LIFE: 4 year
BATCH SIZE: 97.0 Kg DATE STARTED: 23/04/2012
REFERENCE:ICH DATE COMPLETED: 23/10/2012

Results
Test Specification
Initial 1st Month 2nd Month 3rd Month 6th Month

A white or almost white, crystalline White crystalline White crystalline White crystalline White crystalline White crystalline
Characters
powder. powder powder powder powder powder

Slightly soluble in Slightly soluble in Slightly soluble in Slightly soluble in Slightly soluble in
water, very water, very water, very water, very water, very
Slightly soluble in water, very slightly slightly soluble in slightly soluble in slightly soluble in slightly soluble in slightly soluble in
soluble in ethanol (96 per cent), practically ethanol (96 per ethanol (96 per ethanol (96 per ethanol (96 per ethanol (96 per
cent), practically cent), practically cent), practically cent), practically cent), practically
Solubility insoluble in fatty oils. It dissolves in dilute
insoluble in fatty insoluble in fatty insoluble in fatty insoluble in fatty insoluble in fatty
acids and dilute solutions of alkali oils. It dissolves in oils. It dissolves in oils. It dissolves in oils. It dissolves in oils. It dissolves in
hydroxides. dilute acids and dilute acids and dilute acids and dilute acids and dilute acids and
dilute solutions of dilute solutions of dilute solutions of dilute solutions of dilute solutions of
alkali hydroxides. alkali hydroxides. alkali hydroxides. alkali hydroxides. alkali hydroxides.
Identification
By Infrared Test IR spectrum should be match with Positive for Positive for Positive for Positive for Positive for
Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin
Spectrophotometry standard IR spectrum
Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate
pH 3.5 to 5.5 4.6 4.6 4.7 4.7 4.8
Specific optical
+ 290° to + 315° (anhydrous substance) + 296° + 296° + 297° + 297° + 298°
rotation
Related substances
Any impurity Not more than 1.0 per cent 0.3 % 0.3 % 0.3 % 0.4 % 0.4 %
N,N-Dimethylaniline Not more than 20 ppm 9 ppm 9 ppm 10 ppm 10 ppm 11 ppm
Water 11.5 % to 14.5 % 12.4 % 12.5 % 12.5 % 12.6 % 12.6 %

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Sulfated ash Not more than 1.0% 0.4 % 0.5 % 0.5 % 0.6 % 0.6 %
Assay (in %) 95.0 per cent to 102.0 per cent 99.86 99.74 99.51 99.39 99.16

Remarks: The above mention substance under the conditions mention above is stable up to the period of 6 months.

ANALYSED BY: APPROVEDBY:

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Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, India
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 TABLE IV: REAL TIME STABILITY STUDY REPORT
PRODUCT NAME: Amoxicillin Trihydrate BP MFG.Date: 04/2012
STORAGE CONDITIONS: 25°C ± 2°C & RH 60 % ± 5% EXP.Date: 03/2016
BATCH.NO: ST/CPT/001 SHELF LIFE:4 year
BATCH SIZE: 97.0 Kg DATE STARTED: 10/04/2012
REFERENCE:ICH DATE COMPLETED:10/04/2016

Results
Test Specification
6th 9th 12 th 18th 24th 36th 48th
Initial 3rd Month
Month Month month month Month Month Month

A white or almost white, White White White White White White White White White
Characters crystalline crystalline crystalline crystalline crystalline crystalline crystalline crystalline crystalline
crystalline powder.
powder powder powder powder powder powder powder powder powder
Slightly Slightly Slightly Slightly Slightly Slightly Slightly Slightly Slightly
soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in
water, very water, very water, very water, very water, very water, very water, very water, very water, very
slightly slightly slightly slightly slightly slightly slightly slightly slightly
soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in
Slightly soluble in water, very
ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96
slightly soluble in ethanol (96 per cent), per cent), per cent), per cent), per cent), per cent), per cent), per cent), per cent),
per cent), practically insoluble practically practically practically practically practically practically practically practically practically
Solubility
in fatty oils. It dissolves in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in
dilute acids and dilute solutions fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It
of alkali hydroxides. dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in
dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids
and dilute and dilute and dilute and dilute and dilute and dilute and dilute and dilute and dilute
solutions of solutions of solutions of solutions of solutions of solutions of solutions of solutions of solutions of
alkali alkali alkali alkali alkali alkali alkali alkali alkali
hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides.

Identification

Test IR spectrum should be Positive for Positive for Positive for Positive for Positive for Positive for Positive for Positive for Positive for
By Infrared
match with standard IR Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin
Spectrophotometry
spectrum Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate
pH 3.5 to 5.5 4.5 4.5 4.5 4.5 4.6 4.6 4.6 4.7 4.7

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 + 290° to + 315° (anhydrous
Specific optical rotation + 296° + 296° + 296° + 297° + 297° + 297° + 298° + 298° + 298°
substance)
Related substances

Any impurity Not more than 1.0 per cent 0.3 % 0.3 % 0.3 % 0.3 % 0.4 % 0.4 % 0.4 % 0.5 % 0.5 %
N,N-Dimethylaniline Not more than 20 ppm 9 ppm 9 ppm 9 ppm 9 ppm 10 ppm 10 ppm 10 ppm 11 ppm 11 ppm
Water 11.5 % to 14.5 % 12.4 % 12.4 % 12.4 % 12.4 % 12.5 % 12.5 % 12.5 % 12.5 % 12.6 %
Sulfated ash Not more than 1.0% 0.4 % 0.4 % 0.5 % 0.5 % 0.5 % 0.6 % 0.6 % 0.6 % 0.6 %
Assay (in %) 95.0 per cent to 102.0 per cent 99.83 99.79 99.56 99.48 99.25 99.02 98.79 98.56 97.87

Remarks: The above mention substance under the conditions mention above is stable up to the period of 4 years.

ANALYSED BY: APPROVEDBY:

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 TABLE V: REAL TIME STABILITY STUDY REPORT

PRODUCT NAME: Amoxicillin Trihydrate BP MFG.Date: 04/2012

STORAGE CONDITIONS: 25°C ± 2°C & RH 60 % ± 5% EXP.Date: 03/2016
BATCH.NO: ST/CPT/002 SHELF LIFE:4 year
BATCH SIZE: 97.0 Kg DATE STARTED: 15/04/2012
REFERENCE:ICH DATE COMPLETED:15/04/2016

Results
Test Specification
6th 9th 12 th 18th 24th 36th 48th
Initial 3rd Month
Month Month month month Month Month Month

A white or almost white, White White White White White White White White White
Characters crystalline crystalline crystalline crystalline crystalline crystalline crystalline crystalline crystalline
crystalline powder.
powder powder powder powder powder powder powder powder powder
Slightly Slightly Slightly Slightly Slightly Slightly Slightly Slightly Slightly
soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in
water, very water, very water, very water, very water, very water, very water, very water, very water, very
slightly slightly slightly slightly slightly slightly slightly slightly slightly
soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in
Slightly soluble in water, very
ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96
slightly soluble in ethanol (96 per cent), per cent), per cent), per cent), per cent), per cent), per cent), per cent), per cent),
per cent), practically insoluble practically practically practically practically practically practically practically practically practically
Solubility
in fatty oils. It dissolves in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in
dilute acids and dilute solutions fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It
of alkali hydroxides. dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in
dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids
and dilute and dilute and dilute and dilute and dilute and dilute and dilute and dilute and dilute
solutions of solutions of solutions of solutions of solutions of solutions of solutions of solutions of solutions of
alkali alkali alkali alkali alkali alkali alkali alkali alkali
hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides.

Identification

Test IR spectrum should be Positive for Positive for Positive for Positive for Positive for Positive for Positive for Positive for Positive for
By Infrared
match with standard IR Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin
Spectrophotometry
spectrum Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate

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pH 3.5 to 5.5 4.6 4.6 4.6 4.6 4.6 4.6 4.7 4.7 4.7
+ 290° to + 315° (anhydrous
Specific optical rotation + 95° + 95° + 296° + 296° + 297° + 297° + 297° + 298° + 298°
substance)
Related substances

Any impurity Not more than 1.0 per cent 0.3 % 0.3 % 0.3 % 0.4 % 0.4 % 0.4 % 0.5 % 0.5 % 0.5 %
N,N-Dimethylaniline Not more than 20 ppm 9 ppm 9 ppm 9 ppm 10 ppm 10 ppm 10 ppm 10 ppm 11 ppm 11 ppm
Water 11.5 % to 14.5 % 12.4 % 12.4 % 12.5 % 12.5 % 12.5 % 12.5 % 12.5 % 12.6 % 12.6 %
Sulfated ash Not more than 1.0% 0.3 % 0.3 % 0.4 % 0.4 % 0.5 % 0.5 % 0.5 % 0.6 % 0.6 %
Assay (in %) 95.0 per cent to 102.0 per cent 99.77 99.73 99.50 99.42 99.19 98.96 98.73 98.50 97.99

Remarks: The above mention substance under the conditions mention above is stable up to the period of 4 years.

ANALYSED BY: APPROVEDBY:

Pragya Dossier-DMF Services

Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, India
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 TABLE VI: REAL TIME STABILITY STUDY REPORT

PRODUCT NAME: Amoxicillin Trihydrate BP MFG.Date: 04/2012

STORAGE CONDITIONS: 25°C ± 2°C & RH 60 % ± 5% EXP.Date: 03/2016
BATCH.NO: ST/CPT/003 SHELF LIFE:4 year
BATCH SIZE: 97.0 Kg DATE STARTED: 23/04/2012
REFERENCE:ICH DATE COMPLETED:23/04/2016

Results
Test Specification
6th 9th 12 th 18th 24th 36th 48th
Initial 3rd Month
Month Month month month Month Month Month

A white or almost white, White White White White White White White White White
Characters crystalline crystalline crystalline crystalline crystalline crystalline crystalline crystalline crystalline
crystalline powder.
powder powder powder powder powder powder powder powder powder
Slightly Slightly Slightly Slightly Slightly Slightly Slightly Slightly Slightly
soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in
water, very water, very water, very water, very water, very water, very water, very water, very water, very
slightly slightly slightly slightly slightly slightly slightly slightly slightly
soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in soluble in
Slightly soluble in water, very
ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96 ethanol (96
slightly soluble in ethanol (96 per cent), per cent), per cent), per cent), per cent), per cent), per cent), per cent), per cent),
per cent), practically insoluble practically practically practically practically practically practically practically practically practically
Solubility
in fatty oils. It dissolves in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in insoluble in
dilute acids and dilute solutions fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It fatty oils. It
of alkali hydroxides. dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in dissolves in
dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids dilute acids
and dilute and dilute and dilute and dilute and dilute and dilute and dilute and dilute and dilute
solutions of solutions of solutions of solutions of solutions of solutions of solutions of solutions of solutions of
alkali alkali alkali alkali alkali alkali alkali alkali alkali
hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides. hydroxides.

Identification

Test IR spectrum should be Positive for Positive for Positive for Positive for Positive for Positive for Positive for Positive for Positive for
By Infrared
match with standard IR Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin Amoxicillin
Spectrophotometry
spectrum Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate Trihydrate
pH 3.5 to 5.5 4.6 4.5 4.6 4.6 4.6 4.6 4.7 4.7 4.7

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 + 290° to + 315° (anhydrous
Specific optical rotation + 296° + 296° + 296° + 297° + 297° + 297° + 297° + 298° + 298°
substance)
Related substances

Any impurity Not more than 1.0 per cent 0.3 % 0.3 % 0.4 % 0.4 % 0.4 % 0.5 % 0.5 % 0.5 % 0.5 %
N,N-Dimethylaniline Not more than 20 ppm 9 ppm 9 ppm 9 ppm 10 ppm 10 ppm 10 ppm 11 ppm 11 ppm 11 ppm
Water 11.5 % to 14.5 % 12.4 % 12.4 % 12.4 % 12.5 % 12.5 % 12.5 % 12.5 % 12.6 % 12.6 %
Sulfated ash Not more than 1.0% 0.4 % 0.4 % 0.5 % 0.5 % 0.5 % 0.5 % 0.6 % 0.6 % 0.9 %
Assay (in %) 95.0 per cent to 102.0 per cent 99.86 99.82 99.59 99.51 99.28 99.05 98.82 98.59 98.32

Remarks: The above mention substance under the conditions mention above is stable up to the period of 4 years.

ANALYSED BY: APPROVEDBY:

Pragya Dossier-DMF Services

Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, India
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