- Assay / purity
- 99.5–101.0%
- MOQ
- 25 kg
- Lead time
- 7–15 days ex-stock
Gabapentin
1-(Aminomethyl)cyclohexaneacetic acid, Neurontin API · CAS 60142-96-3
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 number | 60142-96-3 |
| Molecular formula | C9H17NO2 |
| Molecular weight | 171.24 g/mol |
| HS code | 2922.49 |
| Synonyms | 1-(Aminomethyl)cyclohexaneacetic acid, Neurontin API |
| Product line | Active Pharmaceutical Ingredients |
| Category | Central 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.
| Parameter | Specification |
|---|---|
| Assay | 98.0–102.0% |
| Related substances | Gabapentin lactam ≤ 0.10%; any unspecified impurity ≤ 0.10% |
| Water content | ≤ 0.5% (Karl Fischer) |
| Heavy metals | ≤ 20 ppm (ICP-MS) |
| Residual solvents | Complies with ICH Q3C Option 1 |
Application
Antiepileptic and neuropathic-pain capsules, tablets and oral solutions.
Packaging, storage & logistics
| Standard packaging | 25 kg fibre drum with double PE liner |
| Minimum order | 25 kg |
| Lead time | 15–25 days |
| Storage conditions | Store below 30 °C, protected from moisture |
| Shipping documents | Invoice, packing list, CoA, SDS, certificate of origin; DGM/IATA declaration where applicable |
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.
Request a quotation
Related products
- Assay / purity
- 98.5–101.5%
- MOQ
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- Lead time
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- Assay / purity
- 95.0–102.0%
- MOQ
- 25 kg
- Lead time
- 15–25 days