Metformin Hydrochloride (A.P.

I) / DC Granules
We have a respectable name in Indian pharma industry owing to our qualitative product named "Metformin Hydrochloride" which is widely used in therapeutic purposes.

PRODUCT Metformin Hydrochloride including Metformin Hydrochloride IP / EP / BP / USP / DC Granules PARTICLE SIZE - Different particle size available, as per customer requirement PACKING - Fiber / H.D.E.P drums with double L.D.E.P bag inside.

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Test Description Solubility Identification

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

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Appearance of solution Related substance by HPLC Heavy metals Loss on drying Sulphated ash Assay

Solution (10% in water) is clear and colorless Cyanoguanidine Any other Impurity Total Impurity Not More Than 10 PPM Not More Than 0.5% Not More Than 0.1% 98.5% - 101.0% N. M. T. = 0.02% N. M. T. = 0.1% N. M. T. = 0.3%

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Certificate of Analysis Product Name Sr. No Test 1 2 Description solubility Metformin Hydrochloride Dc Granules 95% Specification White granules Freely soluble in water, slightly soluble in alcohol practically insoluble, in acetone

and methylene chloride 3 4 5 6 7 8 Identification Loss on drying Related substances (By HPLC) (1) Individual impurity (2) Total impurity Residue on ignition Heavy metals Assay: Each 100 mg granules contains: Metformin Hydrochloride BP 95mg Between 95.0 to 105.0% of label claim. (Between 90.25mg to 99.75mg) 30 mesh: maximum 40 % retained. 60 mesh: maximum 50 % retained. 200 mesh : maximum 80 % retained . Identification for Metformin HCI complies with the SAP/IPM10/01/08. Maximum 2.0% Not more than 0.1 % Not more than 0.5 % Maximum 0.1% Maximum 0.001%

Particle Size Distribution

Certificate of Analysis Product Name Sr. No Test 1 2 3 4 5 6 7 Description Identification Loss On Drying Bulk density Related substances (By HPLC) Sieve Analysis Assay: Each 100 mg granules contains: Metformin Hydrochloride BP 90mg Between 95.0 to 105.0% of label claim. (Between 85.5mg to 94.5mg) Metformin Hydrochloride Dc Granules 90% Specification White granular powder. A. Complies by IR. B. Comply as per BP. C. Comply as per BP. Not More Than 2.0% 0.5gm/cc to 0.7gm/cc Cyananoguanidine NMT 200ppm Individual Impurity NMT 0.1% 40Mesh: NLT 40% Retained NMT 65%. 80Mesh: NMT 35% Retained. 100Mesh: NMT 10% Retained.