Metformin Hydrochloride is an oral antihyperglycemic active pharmaceutical ingredient (API) belonging to the biguanide class. It is widely used as a first-line pharmacological treatment for type 2 diabetes mellitus, together with diet and exercise.
Metformin Hydrochloride helps improve glycemic control primarily by reducing hepatic glucose production and improving insulin sensitivity. It is widely used in immediate-release and extended-release pharmaceutical formulations.
Metformin Hydrochloride has the molecular formula C4H12ClN5 and a molecular weight of 165.62 g/mol. Its CAS Number is 1115-70-4.
It is a white to almost white crystalline powder and is freely soluble in water. Metformin Hydrochloride is the hydrochloride salt of metformin and is widely used in pharmaceutical tablet and oral dosage-form manufacturing.
Metformin primarily decreases hepatic glucose production and improves peripheral insulin sensitivity. It also increases glucose utilization by tissues and may reduce intestinal glucose absorption.
Unlike sulfonylureas, metformin does not directly stimulate pancreatic insulin secretion and therefore has a low intrinsic risk of hypoglycemia when used alone.
Metformin Hydrochloride is used in pharmaceutical formulations for:
The approved indications and combination uses depend on the specific finished pharmaceutical product and applicable regulatory jurisdiction.
Metformin Hydrochloride API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residue on ignition, residual solvents and elemental impurities, as applicable.
HPLC and spectroscopic methods may be used for identification, assay and impurity profiling. Final acceptance criteria should follow the manufacturer's validated drug-substance specification and current Certificate of Analysis.
Metformin Hydrochloride should be stored in a tightly closed pharmaceutical-grade container in a cool, dry environment and protected from excessive moisture and direct light.
Specific storage and transportation requirements should follow the manufacturer's approved specification.
Metformin Hydrochloride API may be supplied for qualified pharmaceutical manufacturing, oral formulation development, analytical testing and research applications, subject to applicable quality and regulatory requirements.
Metformin Hydrochloride is a widely used biguanide API for oral antidiabetic formulations. Product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details can be provided according to applicable pharmaceutical requirements.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 6.5–8.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |