Marketplace › Metformin HCl
Metformin HCl
APICAS 1115-70-4
$3.8–4.6/kg
- Pharmacopeia grade
- IP / USP
- Purity
- 99.5%
- MOQ
- 100 kg
- Lead time
- 3–4 weeks
- Shelf life
- 36 months
- Storage
- 15–25°C, dry
- Sample
- Not offered
Identity & chemistry
- IUPAC name
- 1,1-Dimethylbiguanide Hydrochloride
- Molecular weight
- 165.62g/mol
- ATC code (WHO)
- A10BA02
- Physical form
- Crystalline Powder
- Appearance
- White to off-white crystalline powder
- Solubility
- Freely soluble in water
Quality specification
- Chirality / stereochemistry
- Achiral
- Polymorphic form
- Monocrystalline Form I
- Particle size
- D50: 45–75 µm
- pH range
- 6.68 (1% aqueous solution)
- Loss on drying
- ≤0.5%
- Heavy metals
- ≤10ppm
- Residual solvents
- ICH Q3C Class II — ethanol and acetonitrile residuals tested
- Impurity profile
- Dimethylguanidine ≤0.05%; no genotoxic impurities
Synthesis & starting materials
- Synthesis route
- Condensation of dicyandiamide with dimethylamine sulphate; ICH Q11 step-1 listed
- Starting material
- Dicyandiamide (DCDA); Dimethylamine Sulfate
Regulatory
- DMF type
- Type II
- ASMF number
- EU/ASMF/00198
- IP status
- Generic (Post-Patent)
- Patent expiry
- Expired 1978
Manufacturing & capacity
- Annual capacity
- 2400MT/yr
- Current utilisation
- 65%
Commercial terms
- Price unit
- kg
- MOQ unit
- kg
- Expedited lead time
- 28days
- HSN code (India)
- 29279090
- HS code
- 292690
- GST rate (India)
- 12%
Documentation
- CoA type
- Batch CoA per consignment
- SDS / MSDS available
- Yes
- TDS available
- Yes
- Stability data
- ICH Zones I–IV; 24 months primary, 36 months ongoing
Compliance & documentation
🛡️ US FDA GMPexpires Feb 2028🛡️ EU GMPexpires Jul 2028🛡️ WHO PQexpires Oct 2027🛡️ Manufacturing licence (Form 25/28)expires Aug 2029
🔒 Certificates of Analysis and full certificates are downloadable to signed-in, verified counterparties only.