Metformin HCI USP

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Product Specification

Metformin HCI USP

Test	Specifications
Description	White crystalline powder
Solubility	Freely soluble in water, Slightly soluble in alcohol.
Identification By IR	The infrared absorption spectrum of the sample should concordant with that of the standard spectrum of the Metformin Hydrochloride working standard.
Test for chlorides	Should respond to the test for chlorides
Loss on drying at 105^oC	Not more than 0.50%
Residue on ignition	Not more than 0.10%
Heavy metals	Not more than 0.001%
Related compounds by HPLC Metformin related compound - A Any other Impurity Total Impurities	Not more than 0.02% Not more than 0.10% Not more than 0.50%
Assay by Potentiometry	Not less than 98.5% and Not more than 101.0% (on dried substance)

Product Code : 03

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