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Loratadine

Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate · CAS 79794-75-5

APIs USP / EP CoA per batchSDSGMP statement

A second-generation antihistamine with a clean impurity profile but a demanding particle-size window for ODT formulations. Supplied micronised on request, with the desloratadine (active metabolite) impurity held below 0.10%.

Part of the antihistamine line, where particle size and taste masking are as commercial as the assay.

Identity

Catalogue no.BP-API-014
CAS number79794-75-5
Molecular formulaC22H23ClN2O2
Molecular weight382.89 g/mol
HS code2933.39
SynonymsEthyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate
Product lineActive Pharmaceutical Ingredients
CategoryAntihistamine

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 substancesDesloratadine ≤ 0.10%; any unspecified impurity ≤ 0.10%
Water content≤ 0.5% (Karl Fischer)
Heavy metals≤ 20 ppm (ICP-MS)
Particle sizeD90 ≤ 20 µm (micronised grade on request)
Residual solventsComplies with ICH Q3C Option 1

Application

Non-sedating antihistamine tablets, orally disintegrating tablets and syrups.

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 30 °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 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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