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Azithromycin Dihydrate

Azithromycin dihydrate, 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A dihydrate · CAS 117772-70-0

APIs USP / EP / BP CoA per batchSDSGMP statement

A 15-membered azalide with a hydrate form that has to be preserved through drying — buyers test water content and the azithromycin B impurity together. Supplied as the dihydrate only; the anhydrous form is not offered because it re-equilibrates in suspension.

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-006
CAS number117772-70-0
Molecular formulaC38H72N2O12 · 2H2O
Molecular weight785.03 g/mol
HS code2941.50
SynonymsAzithromycin dihydrate, 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A dihydrate
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
Assay95.0–102.0%
Related substancesAzithromycin B ≤ 1.0%; any unspecified impurity ≤ 0.5%; total impurities ≤ 3.0%
Water content≤ 0.5% (Karl Fischer)
Heavy metals≤ 20 ppm (ICP-MS)
Residual solventsComplies with ICH Q3C Option 1

Application

Macrolide tablets, dry-powder oral suspensions and paediatric sachets.

Packaging, storage & logistics

Standard packaging5 kg / 10 kg aluminium-laminated bag in fibre drum, nitrogen-flushed
Minimum order5 kg
Lead time20–35 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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