Metformin Hydrochloride - Metformin Hydrochloride BP and Metformin Hydrochloride IP

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.

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%

Certificate of Analysis
Product Name	Metformin Hydrochloride Dc Granules 95%

Sr. No	Test	Specification
1	Description	White granules
2	solubility	Freely soluble in water, slightly soluble in alcohol practically insoluble, in acetone and methylene chloride
3	Identification	Identification for Metformin HCI complies with the SAP/IPM10/01/08.
4	Loss on drying	Maximum 2.0%
5	Related substances (By HPLC) (1) Individual impurity (2) Total impurity	Not more than 0.1 % Not more than 0.5 %
6	Residue on ignition	Maximum 0.1%
7	Heavy metals	Maximum 0.001%
8	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)
9	Particle Size Distribution	30 mesh: maximum 40 % retained. 60 mesh: maximum 50 % retained. 200 mesh : maximum 80 % retained .

Certificate of Analysis
Product Name	Metformin Hydrochloride Dc Granules 90%

Sr. No	Test	Specification
1	Description	White granular powder.
2	Identification	A. Complies by IR. B. Comply as per BP. C. Comply as per BP.
3	Loss On Drying	Not More Than 2.0%
4	Bulk density	0.5gm/cc to 0.7gm/cc
5	Related substances (By HPLC)	Cyananoguanidine NMT 200ppm Individual Impurity NMT 0.1%
6	Sieve Analysis	40Mesh: NLT 40% Retained NMT 65%. 80Mesh: NMT 35% Retained. 100Mesh: NMT 10% Retained.
7	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)

» Send Enquiry

Metformin Hydrochloride (A.P.I) / DC Granules