Metformin Hydrochloride IP / BP / USP
Metformin Hydrochloride IP / BP / USP – High-Purity Antidiabetic API for Pharmaceutical Use
Metformin Hydrochloride is a widely used oral antidiabetic active pharmaceutical ingredient (API) belonging to the biguanide class. It is primarily used in the treatment of Type 2 diabetes mellitus to lower blood glucose levels by improving insulin sensitivity and decreasing hepatic glucose production.
Supplied by Nebula Healthcare Ltd., this product complies with Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopeia (USP) standards, ensuring top-tier quality and regulatory compliance for global pharmaceutical formulations.
Chemical Properties:
- Chemical Name: Metformin Hydrochloride
- Chemical Formula: C₄H₁₁N₅·HCl
- Molecular Weight: 165.63 g/mol
- Appearance: White or almost white crystalline powder
- Purity: ≥ 99% (Complies with IP/BP/USP standards)
- Solubility: Freely soluble in water, practically insoluble in acetone, ether, and chloroform
- pH (1% solution): Approximately 6.0–7.0
Applications:
- Pharmaceutical Formulations:
- Immediate-release and extended-release tablets for diabetes treatment
- Fixed-dose combinations with other antidiabetic agents
- Clinical Use:
- First-line medication for Type 2 diabetes
- Polycystic ovary syndrome (PCOS) and insulin resistance treatments (off-label use)
Key Benefits:
- Regulatory Compliant: Meets IP, BP, and USP pharmacopeial specifications
- Proven Efficacy: Clinically validated for glycemic control
- High Stability: Excellent shelf life under recommended storage conditions
- Low Risk of Hypoglycemia: Especially when used as monotherapy
- Cost-Effective: Widely available and affordable API for mass production
Safety Considerations:
Handling: Use gloves, eye protection, and dust masks; avoid inhalation and direct contact
Storage: Store in a cool, dry place in tightly sealed containers, away from light and moisture
Toxicity: Generally well-tolerated; overdose may cause lactic acidosis—use under proper formulation protocols
Disposal: Dispose of in accordance with local pharmaceutical waste regulations