Analytical Testing Record of Finished Product

(As per Schedule U & G.M.P)

Certificate of Analysis

Thiocolchicoside tablets 4 mg
Test _ Report No. : KPA / FP/107 / 1 1457 / 020 / 29296

Lot No. : T-10683 Mfg Date: April 2022 Exp. Date : March 2025 Party Code: P02196

Sample Finish Receipt Date : 04/29/2022 Sample Size : 200 TABLETS Lot Size : 302000 TABLETS

Analista: Suhkveer Singh

Data Analytics

Packaging Presentation : 1 X 10 TABLETS PACKED IN EACH BLISTER STRIP

Tests Specifications Observations

Description It should be yellow colored, round shaped, biconvex saburral tablet Yellow Colorful, Round
film having one side scored and the other side flat. Shaped, Biconvex Film
Saburral Tablet Having
One Side Scored and
Another Flat Side
Identification. In the Assay, the chromatogram obtained with solution test shows at Identified
By. HPLC peak with the same time retention as the main peak in the
chromatogram obtained with solution reference.

An average weight _ 204 milligrams ± 7.5% 205.23 mg.

(Between 188.7 milligrams –219.3 mg).
Weight Uniformity _ ± 7.5% of an average weight. -3,42%, +2,49%

Disintegration Test No more than 30 minutes. 4 minutes.

Dissolution Test _ Not less than 75% (Q) of the labeled amount of thiocolchicoside is 1) 99.9%, 2) 98.2%
dissolved within 45 minutes. Using 90 0ml of buffer phosphate pH 3) 98.5%, 4)96.3%
7.5 as medium with 100 rotations per minute for each paddle. 5)100.7%, 6)98.0%
Uniformity of Dose L1 = Maximum allowable acceptance value for first 10 units is not 4.5
Units more than 15,
L2= Maximum allowable acceptance value for 30 units is no more
than 25
Microbial Limits total aerobic microbial count : TNM 1000 cfu/g total yeast 40 cfu/g.
and mold count : TNM 100 cfu/g Escherichia coli: <10 ufc/g.
Should be absent/gr. Ausente.
Practice Limit Affirm Result %age Protocol Applied
Each tablet contains:
thiocolchicoside 90% - 1 1 0% 4mg 4.08 mg 102,0% In-house speciation

Conclusion : The above product meets high specifications and satisfies the quality standard .