Metformin hydrochloride

Metformin hydrochloride (CAS 1115-70-4) is the active pharmaceutical ingredient form of metformin, supplied as its stable salt for pharmaceutical manufacturing. Known under the alternative designation N,N-Dimethylbiguanide hydrochloride, it is one of the highest-volume oral antidiabetic APIs in global pharmaceutical production.

The primary application is as the API in immediate-release and extended-release oral solid dosage forms, including tablets and film-coated tablets manufactured to pharmacopeial specifications. It is also incorporated into fixed-dose combination products alongside other antidiabetic agents.

This requires precise blending and granulation compatibility during the manufacturing process. Contract manufacturers and generic drug producers source it in bulk for high-throughput tableting lines where consistent particle size and compressibility are critical procurement criteria.

Research institutions and formulation development labs source smaller quantities for bioequivalence studies and novel delivery system development. Metformin hydrochloride is available as a white crystalline powder in bulk quantities suited to commercial-scale pharmaceutical manufacturing.

It is supplied to USP, BP, and Ph. Eur. grades, with grade selection typically driven by the target market's regulatory requirements. Standard packaging ranges from multi-kilogram drums to metric-ton quantities for large-volume generic manufacturers.