Description

Metformin HCl USP

Metformin HCl USP is a high-purity, oral antihyperglycemic agent used in pharmaceutical formulations for the treatment of type 2 diabetes mellitus. As the hydrochloride salt of metformin, this active pharmaceutical ingredient (API) improves insulin sensitivity, reduces hepatic glucose production, and enhances peripheral glucose uptake—making it a first-line therapy in diabetes management.

• USP-compliant biguanide-class antihyperglycemic agent
• Used in oral solid dosage forms for type 2 diabetes treatment and prevention
• Improves insulin sensitivity and lowers fasting blood glucose levels
• Low risk of hypoglycemia and suitable for monotherapy or combination regimens
• Manufactured under Good Manufacturing Practice (GMP) certified conditions
• Supplied with full regulatory documentation including Certificate of Analysis (CoA), Drug Master File (DMF), and supporting technical data

Chemically designated as 1,1-dimethylbiguanide hydrochloride, Metformin HCl USP is a white to off-white crystalline powder, highly soluble in water and practically insoluble in organic solvents. It is rapidly absorbed in the gastrointestinal tract, with no known hepatic metabolism, and is excreted unchanged in urine.

In pharmaceutical applications, Metformin HCl USP is used in:

• Immediate-release (IR) and extended-release (ER) tablets for adults and pediatric patients
• Combination therapies with sulfonylureas, DPP-4 inhibitors, or insulin
• Prediabetes management and off-label use in polycystic ovary syndrome (PCOS)
• Clinical trials and specialty formulations targeting metabolic syndrome and insulin resistance
• Compounded oral suspensions for pediatric and elderly populations

Metformin is recognized for its favorable safety profile, weight neutrality, and cardiovascular benefit potential. It is classified as a first-line oral therapy by major international diabetes guidelines.

CarboMer supplies Metformin HCl USP with validated control over assay, particle size, residual solvents, and microbiological purity. Material is manufactured to United States Pharmacopeia (USP) monograph specifications and is suitable for oral dosage formulation in regulated markets.

Material is packaged in sealed, tamper-evident, moisture-resistant containers. Available in clinical, pilot, and commercial-scale volumes. Minimum order quantities (MOQ), lead times, and documentation—including CoA, SDS, and DMF access—are available upon request.

Each batch is tested for identity (IR, UV), assay (anhydrous basis), loss on drying, residue on ignition, related substances, heavy metals, and microbial contamination. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.

As with all CarboMer oral APIs, Metformin HCl USP is supported by regulatory strategy, formulation assistance, and secure global supply to help you deliver safe, effective diabetes therapies at scale.