Metformin Hydrochloride I.P

Sr. No. Test Specification
1 Appearance White crystalline power
2 Solubility Freely soluble in water, slightly soluble in Alcohol, practically insoluble in Acetone and in Methylene chloride
3 Identification By :

(a) IR IR spectrum of test preparation should be concordant with that of the Metformin Hydrochloride reference standard or working standard preparation.

(b) By Chemically A wine red color develops within 3 minutes.

(c)By Chemically An orange red color is produced which darkens on keeping.

(d) Reaction of chloride It gives chlorides test
4 Loss on Drying at 105 °C Not more than 0.5 % w/w
5 Sulphated Ash Not more than 0.1%
6 Heavy Metals Not more than 20ppm
7 Related substances (By HPLC)

a) Impurity A (Cyanoguanidine) Not more than 0.02%

b) Any other impurity Not more than 0.1 %
8 Assay (By Potentiometry,% w/w On dried basis) 98.5% to 101.0%
ADDITIONAL TEST
9 Residual solvent (By G.C.ppm)

a) Xylenes Not more than 2170 ppm

b) Methanol Not more than 3000 ppm