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Gliclazide

1-(Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-(p-tolylsulfonyl)urea · CAS 21187-98-4

APIs USP / EP / BP CoA per batchSDSGMP statement

A second-generation sulfonylurea with a narrow therapeutic index, so assay and content uniformity carry the risk. Supplied to the EP monograph with particle size held constant between lots — MR formulations are sensitive to it.

Part of the cardiovascular and metabolic line — chronically dosed actives where the impurity profile, not the assay, decides whether a lot is accepted.

Identity

Catalogue no.BP-API-011
CAS number21187-98-4
Molecular formulaC15H21N3O3S
Molecular weight323.41 g/mol
HS code2935.90
Synonyms1-(Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-(p-tolylsulfonyl)urea
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
Assay99.0–101.0%
Related substancesAny unspecified impurity ≤ 0.10%; total impurities ≤ 0.5%
Water content≤ 0.5% (Karl Fischer)
Heavy metals≤ 20 ppm (ICP-MS)
Particle sizeD90 30–80 µm, lot-to-lot controlled

Application

Modified-release and immediate-release oral antidiabetic tablets.

Packaging, storage & logistics

Standard packaging25 kg fibre drum with double PE liner
Minimum order25 kg
Lead time20–30 days
Storage conditionsStore below 25 °C, protected from light
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

  • CoA per batchBatch-specific, tested against the specification agreed at PO stage
  • SDSCurrent GHS revision; destination-language version on request
  • GMP statementSite-level GMP status and the last audit date, issued per customer

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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