TEST

SPECIFICATION AS PER BP

Description

A white coloured round shaped, biconvex, film coated tablets with break-line on one side.

Identification (IR)

The IR spectrum of the sample should be concordant with the reference spectrum of metformin hydrochloride.

Thickness

4.80 mm ± 0.2 mm

Diameter

13.10 mm ± 0.2 mm

Average Weight

583.00 mg ± 5%

Uniformity of weight

within ± 5% of average weight

Disintegration Time

NMT 30 min in water medium at 37°C

Dissolution

NLT 70.0%

1-Cyanoguanidine

Must comply as per BP

Assay - Each film coated tablet contains: Metformin Hydrochloride BP: 500mg

95.0% to 105.0%