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Atorvastatin Calcium

Atorvastatin calcium trihydrate, (3R,5R)-atorvastatin calcium · CAS 134523-00-5

APIs USP / EP USDMF Type IICEPCoA per batchSDS

Atorvastatin calcium is oxygen- and light-sensitive, and its polymorphic form determines both dissolution and stability. We supply the amorphous form with a polymorph statement, nitrogen-flushed packaging and a batch stability summary covering the standard 24-month shelf life.

Impurity control here is the expensive part: the desfluoro and diastereomer impurities are specified individually rather than lumped into a total. If your dossier was written against a different impurity numbering, send it across and we will map our CoA to your method.

Identity

Catalogue no.BP-API-005
CAS number134523-00-5
Molecular formulaC66H68CaF2N4O10
Molecular weight1155.36 g/mol
HS code2933.99
SynonymsAtorvastatin calcium trihydrate, (3R,5R)-atorvastatin calcium
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
Assay98.0–102.0% (HPLC, on anhydrous basis)
Related substancesDesfluoro impurity ≤ 0.20%; any unspecified ≤ 0.10%
Total impuritiesTotal impurities ≤ 1.0%
Loss on dryingWater content ≤ 4.0% (Karl Fischer)
Residue on ignitionResidue on ignition ≤ 0.2%
Heavy metalsHeavy metals ≤ 20 ppm
PolymorphAmorphous (XRD statement)
Specific rotation−7.0° to −9.0°
PackagingNitrogen-flushed, light-resistant

Application

Statin tablets for hypercholesterolaemia, including fixed-dose combinations.

Packaging, storage & logistics

Standard packaging5 kg / 10 kg aluminium-laminated bag in fibre drum, nitrogen-flushed
Minimum order5 kg
Lead time20–30 days
Storage conditionsStore at 2–8 °C for long-term, protected from light and oxygen
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

  • USDMF Type IIOpen part available under confidentiality agreement for CMC review
  • CEPCertificate of Suitability to the European Pharmacopoeia, issued by EDQM
  • CoA per batchBatch-specific, tested against the specification agreed at PO stage
  • SDSCurrent GHS revision; destination-language version on request
  • Polymorph statementCrystal form confirmed by XRD on the shipped lot

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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