Metformin Hcl
CAS No. number 1115-70-4
Molecular Structure
Metformin Hcl
STANDARD TESTING SPECIFICATIONS
Metformin Hydrochloride EP/BP/USP
Product Name: Metformin Hydrochloride
CAS No.: 1115-70-4
Molecular Formula: C4H11N5·HCl
Molecular Weight: 165.62
Specification: USP/BP/EP
Chemical Name: N,N-Dimethylimidodicarbonimidic diamide hydrochloride
Physical Form: White or almost white crystalline Powder with a Scarcely perceptible yellow tinge.
ATC code A10BA02
A10BD02 (with sulfonylureas)
A10BD05 (with pioglitazone)
A10BD07 (with sitagliptin)
A10BD08 (with vildagliptin)
PubChem 4091
DrugBank APRD01099
Chemical data
Formula C4H11N5
Mol. mass 129.164 g/mol
165.63 g/mol (hydrochloride)
Synonyms 1,1-dimethylbiguanide
Pharmacokinetic data
Bioavailability 50 to 60% under fasting conditions
Metabolism None
Half life 6.2 hours
Excretion Active renal tubular excretion by OCT2
Therapeutic Cat: Anti-diabetic
Related substances: dicyandiamide0.02%max: complies any other impuritles0.1%max complies
Heavy metals: 10ppm
Loss on drying: 0.5%max
Sulphated ash: 0.1%max
Assay: 98.54-101%
Documents Available USDMF / EDMF
Solubility Soluble to 100 mM in water and to 50 mM in DMSO
Use/Stability : Stock solutions are stable for up to 6 months when stored at -20°C.
Long term Storage: +4°C
Biological Activity: Antidiabetic agent; lowers plasma glucose levels and improves insulin sensitivity.
Inhibits hepatic gluconeogenesis via activation of the LKB1/AMPK pathway.
Displays antiproliferative effects in cancer cell lines.
Synonyms Metformin Hydrochloride ; N,N-dimethylimidodicarbonimidic diamide
Hydrochloride; 1,1-dimethylbiguanide Hydrochloride; N,Ndimethyldiguanide
Hydrochloride; 1,1-dimethylbiguanide
monohydrochloride;
Handling: HYGROSCOPIC.
Hazard: IRRITANT.
Properties
Melting point: 223-226ºC
Safety Data
Hazard Symbols: Xn
Risk Codes: R22;R36/38
Safety Description S26;S36
Production Capacity 900 MT per annum
Packing Details 50 Kgs Fibre drums
Identification: Ir/TLC idcntification /pink colour/chlorides test----cino\plies
Appearance of solution: clear , colourless
Type: Endocrine System Agents
Detailed Product Description
Indications: oral antihyperglycemic agent
Advantages: sustained release pellets, last more long, better effection
Product name: Metformin hydrochloride SR pellets
Indications: antihyperglycemic
Advantages: sustained release pellets , last more long, better effection
Ingredient: Metformin hydrochloride, coating agent for SR, stability agent, etc
DISPOSAL CONSIDERATIONS
Waste from residues / unused products:
Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product, if
unaltered by use, may be disposed of by treatment at a permitted facility or as advised by your local hazardous
waste regulatory authority. Residue from fires extinguished with this material may be hazardous.
