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Gabapentin

1-(Aminomethyl)cyclohexaneacetic acid, Neurontin API · CAS 60142-96-3

APIs USP / EP CoA per batchSDSGMP statement

An amino acid API that lactamises in the presence of moisture, so the gabapentin lactam impurity and water content are the two release-critical numbers. Supplied with a desiccant-stabilised pack and a re-test period rather than an expiry.

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

Identity

Catalogue no.BP-API-010
CAS number60142-96-3
Molecular formulaC9H17NO2
Molecular weight171.24 g/mol
HS code2922.49
Synonyms1-(Aminomethyl)cyclohexaneacetic acid, Neurontin 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
Assay98.0–102.0%
Related substancesGabapentin lactam ≤ 0.10%; any unspecified impurity ≤ 0.10%
Water content≤ 0.5% (Karl Fischer)
Heavy metals≤ 20 ppm (ICP-MS)
Residual solventsComplies with ICH Q3C Option 1

Application

Antiepileptic and neuropathic-pain capsules, tablets and oral solutions.

Packaging, storage & logistics

Standard packaging25 kg fibre drum with double PE liner
Minimum order25 kg
Lead time15–25 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

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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