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Omeprazole

5-Methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole · CAS 73590-58-6

APIs USP / EP / BP CoA per batchSDSGMP statement

A benzimidazole that degrades fast in acid and slowly in light — hence the enteric coat and the light-resistant pack. Supplied as a free-flowing powder with the sulfone and sulfide impurities individually controlled, since both are method-sensitive.

Part of the gastrointestinal line. Most of these are acid-labile, so the discussion usually starts with the enteric coat rather than the API.

Identity

Catalogue no.BP-API-018
CAS number73590-58-6
Molecular formulaC17H19N3O3S
Molecular weight345.42 g/mol
HS code2933.39
Synonyms5-Methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole
Product lineActive Pharmaceutical Ingredients
CategoryGastrointestinal

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 substancesOmeprazole sulfone ≤ 0.10%; omeprazole sulfide ≤ 0.10%; total impurities ≤ 0.5%
Water content≤ 0.5% (Karl Fischer)
Heavy metals≤ 20 ppm (ICP-MS)
Residual solventsComplies with ICH Q3C Option 1

Application

Enteric-coated proton-pump-inhibitor pellets and capsules.

Packaging, storage & logistics

Standard packaging25 kg fibre drum with double PE liner, light-resistant
Minimum order25 kg
Lead time15–25 days
Storage conditionsStore below 25 °C, protected from light and humidity
Shipping documentsInvoice, packing list, CoA, SDS, certificate of origin; DGM/IATA declaration where applicable

Pack sizes available — pick one to prefill the enquiry

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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