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Losartan Potassium

Losartan potassium salt, 2-butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol monopotassium · CAS 124750-99-8

APIs USP / EP CoA per batchSDSGMP statement

A tetrazole API that is hygroscopic in the free-acid form and only workable as the potassium salt. Water content and the trityl-related impurity drive the specification; both are released per lot with the chromatogram attached.

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-015
CAS number124750-99-8
Molecular formulaC22H22ClKN6O
Molecular weight461.01 g/mol
HS code2933.99
SynonymsLosartan potassium salt, 2-butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol monopotassium
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%
Related substancesTrityl alcohol ≤ 0.10%; any unspecified impurity ≤ 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

Antihypertensive film-coated tablets and losartan/hydrochlorothiazide combinations.

Packaging, storage & logistics

Standard packaging1 kg / 5 kg aluminium-laminated foil bag in fibre drum
Minimum order10 kg
Lead time20–30 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

100 g1 kg5 kg25 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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