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Levetiracetam

(S)-2-(2-Oxopyrrolidin-1-yl)butanamide, Keppra API · CAS 102767-28-2

APIs USP / EP CoA per batchSDSGMP statement

Chiral, and the (R)-enantiomer is the impurity that decides whether a lot can be released — it is controlled by chiral HPLC at 0.05%. The molecule is otherwise stable, which is why it is one of the easier CNS APIs to qualify.

Part of the CNS line. Narrow therapeutic index actives: expect a specification review before any sample is dispatched.

Identity

Catalogue no.BP-API-013
CAS number102767-28-2
Molecular formulaC8H14N2O2
Molecular weight170.21 g/mol
HS code2933.79
Synonyms(S)-2-(2-Oxopyrrolidin-1-yl)butanamide, Keppra API
Product lineActive Pharmaceutical Ingredients
CategoryCentral Nervous System

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
Assay98.5–101.5%
Related substances(R)-enantiomer ≤ 0.05%; any unspecified impurity ≤ 0.10%
Water content≤ 0.5% (Karl Fischer)
Heavy metals≤ 20 ppm (ICP-MS)
Chiral purityEnantiomeric ratio by chiral HPLC
Residual solventsComplies with ICH Q3C Option 1

Application

Antiepileptic tablets, oral solution and intravenous concentrate.

Packaging, storage & logistics

Standard packaging25 kg fibre drum with double PE liner
Minimum order25 kg
Lead time20–30 days
Storage conditionsStore below 30 °C, protected from moisture
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 kg25 kg500 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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