Metformin Hydrochloride is a high-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) belonging to the biguanide class of antihyperglycemic medicines. It is the hydrochloride salt of metformin and is widely used in pharmaceutical formulations for the management of type 2 diabetes mellitus. MEDIOCON INC supplies quality-focused Metformin Hydrochloride API for pharmaceutical formulation, product development and bulk API requirements.
Metformin Hydrochloride is also known as Metformin HCl, Metformin Hydrochloride, 1,1-Dimethylbiguanide Hydrochloride and Imidodicarbonimidic Diamide, N,N-Dimethyl-, Monohydrochloride. Its CAS number is 1115-70-4, molecular formula is C₄H₁₂ClN₅, and molecular weight is 165.62 g/mol. PubChem confirms these chemical identity details and identifies Metformin Hydrochloride as the hydrochloride salt of metformin.
Metformin Hydrochloride is generally described as a white crystalline powder and is freely soluble in water, with pharmaceutical references describing its characteristic high aqueous solubility. The substance is a strongly polar biguanide salt and is commonly supplied as a pharmaceutical-grade API for tablet and other oral dosage-form manufacturing.
Metformin acts primarily by reducing hepatic glucose production and improving insulin sensitivity. It is widely used as an oral antihyperglycemic pharmaceutical substance and is an important API in the manufacture of immediate-release and extended-release metformin formulations.
The USP monograph currently available from the United States Pharmacopeia defines Metformin Hydrochloride as containing NLT 98.0% and NMT 102.0% of metformin hydrochloride, calculated on the dried basis. The USP monograph identifies USP Metformin Hydrochloride RS and USP Metformin Related Compound A RS as reference standards.
The detailed USP quality requirements include controls for loss on drying, residue on ignition, heavy metals and related compounds. The accessible USP monograph specifies loss on drying at NMT 0.5%, residue on ignition at NMT 0.1%, and heavy metals at 0.001% (10 ppm). Related Compound A, identified as 1-cyanoguanidine, is controlled at NMT 0.02%, while any other individual impurity is limited to NMT 0.1% and total impurities to NMT 0.5%.
MEDIOCON INC supplies Metformin Hydrochloride API for pharmaceutical formulation, analytical development and commercial pharmaceutical requirements. Supporting documentation such as Certificate of Analysis (COA), MSDS/SDS and applicable technical specifications can be provided according to product specification and customer requirements.
Metformin Hydrochloride should be stored in well-closed containers under appropriate controlled conditions. The USP monograph specifies storage at room temperature.
MEDIOCON INC focuses on quality-oriented supply of Metformin Hydrochloride API for domestic and international pharmaceutical customers.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR & HPLC Complies |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.1%NMT 0.1% |
| Total Impurities | NMT 0.5% |
| Water Content | NMT 0.5% |
| Melting Point | 222°C – 226°C |
| Solubility | Freely soluble in water |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Metformin Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC (CAS 1115-70-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Metformin Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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