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Metformin Hydrochloride

1,1-Dimethylbiguanide hydrochloride · CAS 1115-70-4

APIs USP / EP / BP / IP CEPUSDMF Type IVCoA per batchSDS

Metformin is a high-dose API — 500 to 1000 mg per tablet — which means impurity limits, not assay, drive the cost of a compliant batch. Nitrosamine control (NDMA, NDEA) is the first question every EU and US buyer now asks, and we supply a batch-specific statement with the CoA.

Because the molecule is highly water-soluble and hygroscopic, we recommend moisture-barrier packaging for long sea-freight routes. We will quote either aluminium-laminated drums or standard fibre drums with an inner LDPE bag, depending on destination climate.

Identity

Catalogue no.BP-API-016
CAS number1115-70-4
Molecular formulaC4H11N5 · HCl
Molecular weight165.62 g/mol
HS code2925.29
Synonyms1,1-Dimethylbiguanide hydrochloride
Product lineActive Pharmaceutical Ingredients
CategoryCardiovascular & Metabolic

Release specification

Catalogue standard below. For a supply agreement we release against your dossier specification; send it with the enquiry and the CoA will be built around it.

ParameterSpecification
Assay98.5–101.0% (titration, on dried basis)
Related substancesImpurity A ≤ 0.02%; any other individual ≤ 0.10%
Total impuritiesTotal impurities ≤ 0.50%
Loss on dryingLoss on drying ≤ 0.5%
Residue on ignitionResidue on ignition ≤ 0.1%
Heavy metalsHeavy metals ≤ 20 ppm
Melting range222–226 °C
NDMA≤ 0.03 ppm (batch statement)
Water content≤ 0.5% (Karl Fischer)

Application

Type 2 diabetes formulations — immediate and extended release tablets.

Packaging, storage & logistics

Standard packaging25 kg fibre drum with double PE liner; 1000 kg jumbo bag
Minimum order100 kg
Lead time10–20 days
Storage conditionsStore in tightly closed containers, protected from moisture
Shipping documentsInvoice, packing list, CoA, SDS, certificate of origin; DGM/IATA declaration where applicable

Pack sizes available — pick one to prefill the enquiry

100 g1 kg25 kg500 kg

Documentation provided

  • CEPCertificate of Suitability to the European Pharmacopoeia, issued by EDQM
  • USDMF Type IVOpen part available for excipient, colourant and packaging applications
  • CoA per batchBatch-specific, tested against the specification agreed at PO stage
  • SDSCurrent GHS revision; destination-language version on request
  • NDMA / NDEA statementBatch-specific nitrosamine data for EU and US filings

Need the DMF open part, a sample CoA or an audit pack before you can qualify us? Ask on the enquiry form — we send those documents before any commercial discussion.

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