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Ciprofloxacin Hydrochloride

Ciprofloxacin HCl, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride · CAS 86393-32-0

APIs USP / EP / BP CoA per batchSDSGMP statement

The hydrochloride is the workable form of a fluoroquinolone that is otherwise poorly soluble. Fluoroquinolonic acid — the classic synthesis by-product — is the impurity buyers screen for, and it is controlled to 0.2% with the method cited.

Part of the anti-infective line. These are the products where a supplier switch triggers a regulatory filing, so the CoA history and the impurity methods travel with the material.

Identity

Catalogue no.BP-API-007
CAS number86393-32-0
Molecular formulaC17H18FN3O3 · HCl
Molecular weight367.81 g/mol
HS code2933.49
SynonymsCiprofloxacin HCl, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride
Product lineActive Pharmaceutical Ingredients
CategoryAnti-infective

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
Assay99.0–102.0%
Related substancesFluoroquinolonic acid ≤ 0.20%; any unspecified impurity ≤ 0.20%; total impurities ≤ 0.5%
Water content≤ 0.5% (Karl Fischer)
Heavy metals≤ 20 ppm (ICP-MS)
Residual solventsComplies with ICH Q3C Option 1

Application

Fluoroquinolone tablets, infusion concentrates and ophthalmic solutions.

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 and moisture
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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