CERTIFICATE OF ANALYSIS

Product Name
Batch No. A. R. No. IP/22/0169
THKP322068
Mfg. Date 05/2022 Date of Analysis 26/05/2022
Exp. Date 04/2026 Quantity 250.0 kg

Sr. No. Test Result Specification

01 Appearance White crystalline powder. White or almost white, crystalline powder
02 Solubility Freely soluble in water and in Freely soluble in water and in methanol
methanol, soluble in ethanol soluble in ethanol (96%).
(96%).
03 Melting point 261°C with decomposition About 260°C, with decomposition
04 Identification test
(A) By Optical rotation (+) 0 0160“ Between (-) 0.2° and (+) 0.2°
(B) By IR The IR spectrum of sample is in The IR spectrum of sample should be in
concordant with the IR concordant with the IR spectrum of the
spectrum of the standard standard
(C) By Chloride test Gives the reaction of chlorides Gives the reaction of chlorides.
05 Appearance of solution Solution S is clear and Solution S should be clear and colourless.
colourless
06 pH 37 Between 3,5 and 4.1
07 Optical rotation ) 0 0160° Between ) 0.2° and (+) 0.2°
08 Related substance by HPLC
Impurities A, B, C
Unspecified impurities Not detected Each impurity is not more than 0.20 %
Total impurities Not detected Each impurity is not more than 0 10 %
Not detected Not more than 0.50 %
09 Loss on drying 0.12 % Not more than 0.50 %
10 Sulphated ash 0.04 % Not more than 0 10 %
11 Assay (On dried basis) 99.8 % Between 99 0 % and 101.0 %
42 Residual Solvent by GC
Methanol 16 ppm Not more than 3000 ppm
Acetone Not detected Not more than 5000 ppm
Isopropyl Alcohol 77 ppm Not more than 5000 ppm
Toluene Not detected Not more than 890 ppm
Ortho Dichloro Benzene Not detected Not more than 870 gpm
Additional test
13 Microbial limit test
Total bacterial count Nil Not more than 100 CFU/ml
Total fungal count Nil Not more than 10 CFU/ml
Pathogens
E.cOli
Absent Should be absent
P.aerugenosa Absent Should be absent
S aureus Absent Should be absent
Salmonella sp Absent Should be absent
OPINION: The product Complies as per BP/EP specification

*.
Checked by /“
H. I. Patel Sha'nâ r gaulick
Chemist - QC Manager - QC
 CERTIFICATE OF ANALYSIS

Product Name
Batch No. THKP322069 A. R. No. FP/22/0170
Mfg. Date 05/2022 Date of Analysis 27/05/2022
Exp. Date 04/2026 Quantity 250.0 kg.

Sr. No. Test Result Specification

01 Appearance White crystalline powder. White or almost white, crystalline powder
02 Solubility Freely soluble in water and in Freely soluble in water and in methanol,
methanol, soluble in ethanol soluble in ethanol (96%)
(96%)
03 Melting point 261°C with decomposition. About 260°C, with decomposition
04 Identification test
(A) By Optical rotation (+) 0 0111° Between (-) 0.2° and (+! 0.2°
tB) By IR The IR spectrum of sample is in The IR spectrum of sample should be in
concordant with the IR concordant with the IR spectrum of the
spectrum of the standard standard
(C) By Chloride test Gives the reaction of chlorides Gives the reaction of chlorides.
05 Appearance of solution Solution S is clear and Solution S should be clear and colourless.
colourless.
06 pH 37 Between 3.5 and 4.1
07 Optical rotation (+) 0 0111° Between (-) 0.2° and (+) 0.2°
08 Related substance by HPLC
Impurities A, B, C
Unspecified impurities Not detected Each impurity is not more than 0.20 %
Total impurities Not detected Each impurity is not more than 0.10 %
Not detected Not more than 0.50 %
09 Loss on drying 0.19 % Not more than 0.50 %
10 Sulphated ash 0.04 % Not more than 0.10 %
11 Assay (On dried basis) 99.8 % Between 99.0 % and 101.0 %
12 Residual Solvent by GC
Methanol 20 ppm Not more than 3000 ppm
Acetone Not deeced Not more than 5000 ppm
lsopropyl Alcohol 68 ppm Not more than 5000 ppm
Toluene 3 ppm Not more than 890 ppm
Ortho Dichloro Benzene Not deeced Not more than 1870 pP^
Additional test
13 Microbial limit test
Total bacterial count Nil Not more than 100 CFU/ml
Total fungal count Nil Not more than 10 CFU/mT
Pathogens
E.coli Absent Should be absent
P.aerugenosa Absent Should be absent
S.aureus Absent Should be absent
Salmonella sp Absent Should be absent ,

OPI N: The product Complies as per BP/EP specification.

Checked by Approved by
H. I. Patel Shankar Maulick
Chemist QC Manage