Sohan Healthcare Pvt. Ltd.
Sohan Healthcare Pvt. Ltd.
Metformin Hydrochloride drugs Metformin Hydrochloride BP
manufacturers & exporters of
Pharmaceutical Ingredients
like Metformin Hydrochloride (A.P.I.)
Metformin Hydrochloride EP
Home » Metformin Hydrochloride (A.P.I) / DC Granules

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

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

 
Metformin Hydrochloride Tablet
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)