METFORMIN HYDROCHLORIDE

Metformin Hydrochloride is a first-line oral antidiabetic API belonging to the biguanide class, widely used in the management of Type 2 diabetes mellitus. It helps control high blood sugar levels by reducing hepatic glucose production, increasing insulin sensitivity, and enhancing peripheral glucose uptake.

At Bluepill Express, we manufacture and export pharmacopeial-grade Metformin Hydrochloride API under WHO-GMP, ISO, and cGMP certified facilities. Our API complies with IP, BP, USP, and EP standards, offering assay purity ≥99%, low impurity levels, and consistent particle size distribution to ensure high performance in tablet, capsule, and sustained-release formulations.

Metformin Hydrochloride is a globally preferred active ingredient for formulating antidiabetic medications, both as monotherapy and in combination with other agents like Sitagliptin, Glimepiride, and Vildagliptin.

Therapeutic Applications:

• Management of Type 2 Diabetes Mellitus
• Improves glycemic control and reduces HbA1c levels
• Used in combination with other oral hypoglycemics or insulin therapy
• Beneficial for polycystic ovary syndrome (PCOS) due to insulin resistance
• May help in weight management for diabetic patients

Mechanism of Action:

Metformin Hydrochloride works primarily by inhibiting hepatic gluconeogenesis, thereby lowering glucose production in the liver. It also increases insulin receptor sensitivity, facilitating better glucose uptake by peripheral tissues and reduces intestinal glucose absorption, resulting in improved overall glycemic control without causing hypoglycemia.

Technical Specifications:

• Chemical Name: N,N-Dimethylimidodicarbonimidic diamide hydrochloride
• Molecular Formula: C₄H₁₂ClN₅
• Molecular Weight: 165.62 g/mol
• CAS Number: 1115-70-4
• Appearance: White or off-white crystalline powder
• Assay (on dried basis): NLT 98.5% and NMT 101.0%
• Solubility: Freely soluble in water; insoluble in acetone, ether, and chloroform
• Melting Point: 222°C – 226°C (decomposes)
• Storage Conditions: Store below 30°C in a dry, well-ventilated area, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Antidiabetic / Hypoglycemic Agent
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications: Tablets (Immediate & Extended Release), Capsules, Oral Suspensions

Manufacturing Excellence – Bluepill Express:

• Produced under WHO-GMP, ISO 9001:2015, and cGMP certified facilities
• High assay value (≥99%) ensuring consistent efficacy
• HPLC-tested for impurities and uniform particle distribution
• DMF-ready with complete technical and analytical documentation
• Custom particle size control suitable for ER and IR formulations
• Complies with ICH Q7 and Q3A/B impurity guidelines

Advantages of Bluepill Express Metformin Hydrochloride API:

• Pharmacopeial-grade quality with global compliance
• DMF & COA support for regulatory filings
• Excellent flow properties for large-scale tablet manufacturing
• Batch consistency and traceability ensured
• Customized export packaging with long shelf stability

Packaging & Export Information:

• Standard Pack Sizes: 5 kg, 25 kg HDPE drums with double LDPE liners
• Labeling: As per international pharmacopeial norms
• Shelf Life: 36 months under recommended conditions
• Export Destinations: Africa, Middle East, Asia, Europe, Latin America
• Documentation Support:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Stability Data Sheet (SDS)
  • Drug Master File (DMF)