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CERTIFICATE OF ANALYSIS
Product THIOCOLCHICOSIDE _ IP A.R. No. TCSl047l22

Molecular formula CzzHr:NOroS CAS No. 602-41-5

Batch No. QU/TCS/046/22 Date of Analysis 26.tl.2022

Mfg. Date NOV.-2022 Exp. Date ocT.-2027

COA Release Date 16.12.2022 Release Quantity 05.000 Kg.

Customer Name NVs Viraj Pharma

S. No. Test Specilication Result

I Description A yellow crystalline powder. Complies

1 Solubility Soluble in water, Very slightly soluble in Ethanol 95% Complies

Identification
a)By IR IR spectra should match with that of standard. Complies

3. b)By UV When examined in the range of 220nm to 440nm, a Complies

0.0015%w/v solution in water shows absorption
maxima at the same wavelength as obtained with the
reference solution.
4. pH (0.5% w/v solution in water) Between 6.0 and 7.5 6.2
Specific Optical rotation [o] 23 D (-) 550" to (-) 560.2"
5.
(Determined on 0.5% solution in water) O 580'
6. Sulphated Ash Not more than 0.1%w/w 0.06 o/ow/w

Loss on drying (105"C for 3 hrs) Not more than 4.0Yowlw 2.8 o/ow/w
Related Substances (By HPLC)
a) N-deactyl N-formyl Thiocolchicoside Not more than 0.5% 0.22%
8.
b) Colchicoside Not more than 0.5% 0.31o/o
c) Sum of other impurity Not more than 0.5% 0.25%
9. Bacterial f,ndotoxin Not more than 87.5 EU/mg. Complies
Not less than 98.0% to Not more than 102.0% of
10. Assay (By HPLC) on dried basis. 99.6 o/ow/w
Thiocolchicoside (CzzH::NOroS).
Microbial contamination
Total microbial count Not more than I000 cfu/g Complies
Fungi ( Yeast & Mould) count Not more than 100 cfu/g. Complies
E.coli/g Free from E. coli Absent
11 Salmonella/l0g Free from Salmonella Absent
S.aureus/g Free from S.aureus Absent
P.aeruginosa/g Free from P.aeruginosa Absent
Enterobacteri aceaelg Free from Enterobacteriaceae Absent
Shieella/ l0s Irree from Shieella Absent
Remarks: The material .orfi,fr., / dses*etconapt as per lP specification.
Storage: Store protected from light and at a temperature not exceeding 300C.

Prepared By Checked By Approved By

(E:ecutive - Q.A.) (Manager - Q.C.) (Manager - Q.A.)

Signature
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