INPROCESS QUALITY CONTROL REPORT

Product Name : INDO METFORMIN 850 TABLETS

Generic Name : METFORMIN 850 mg Tablets
Product Code : 256 A.R. No. : ARC/17/091
Batch No. : 2561748 Report Date : 24/06/2017
Mfg. Date : Jun-2017 Batch Size : 5,50,000Tablets
Exp. Date : May-2019 Pack size : 6 x 14 tablets
QC Spec. No. : FP-240/1.1 Blister Pack

Sr.
Test Limits Results
No.
1. Description Biconvex, white, film coated, round Complies
tablets.
2. Average Weight 953.35-1053.71 mg 1003.37 mg

3. Uniformity of weight 953.35-1053.71mg Min.: 977.43 mg

Max.:1021.20 mg
4. Diameter 13.3mm -13.7 mm 13.57 mm-13.62 mm

5. Thickness 6.9-7.3 mm 6.99 mm-7.11 mm

6. Disintegration time Maximum 30 minutes in water. 10 minutes and 21

seconds
7. Identification

a. Infra Red absorption Concordant with standard reference Complies

spectrum spectrum
b. Colour Reaction Orange red colour is produced which Complies
darkens on standing
c. Chlorides The precipitate dissolves easily with the Complies
possible exception of a few large
particles which dissolve slowly
8. Identification of titanium Orange red colour is produced Complies
dioxide
9. Assay, Content of 95.00% to 105.00 % of labeled amount 857.61mg
Metformin hydrochloride 807.5 892.5 mg 100.90%

Form no.: QC/007/256 Page 1 of 2

 INPROCESS QUALITY CONTROL REPORT
Product Name : INDO METFORMIN 850 TABLETS
Generic Name : METFORMIN 850 mg Tablets
Product Code : 256 A.R. No. : ARC/17/091
Batch No. : 2561748 Report Date : 24/06/2017
Mfg. Date : Jun-2017 Batch Size : 5,50,000Tablets
Exp. Date : May-2019 Pack size : 6 x 14 tablets
QC Spec. No. : FP-240/1.1 Blister Pack

Sr.
Test Limits Results
No.
10. Related substances
a) Cyanoguanidine a) 0.02 % maximum

b) Secondary impurity single b) 0.1 % maximum

c) Secondary impurity total c) 0.3 % maximum

d) Total impurities d) 0.32 % maximum

11. Dissolution NLT 70% is dissolved in 45 minutes Min.: 98.45%

Max.: 100.12%
Mean.:99.34%(Unit
tested=6)

The product meets / does not meets the specification of INDO METFORMIN 850 Tablets
and hence is/is not of standard quality.

For Rusan Pharma Ltd.

Q.C. Incharge

Form no.: QC/007/256 Page 2 of 2