Sr. No

Test

Specification

1

Description

White crystals

2

Solubility

Freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride.

3

Identification

A. Melting Point: - 222 deg C. to 226 deg C.

B. IR Spectrum: - Examine by infrared absorption spectrophotometer, comparing with the spectrum obtained with Metformin hydrochloride.

C. By TLC: - The principal spot in the chromatogram obtained with the test solution is similar in position, color and size to the principal spot in the chromatogram obtained with reference solution.

D. Color test: - A pink color develops

E. Chloride: - It gives reaction of chlorides.

4

Appearance of solution

Solution (10% in water) is clear and colorless

5

Related substance by HPLC

Cyanoguanidine

N. M. T. = 0.02%

Any other Impurity

N. M. T. = 0.1%

Total Impurity

N. M. T. = 0.3%

6

Heavy metals

Not More Than 10 PPM

7

Loss on drying

Not More Than 0.5%

8

Sulphated ash

Not More Than 0.1%

9

Assay

98.5% - 101.0%