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Paracetamol (Acetaminophen)

Acetaminophen, N-Acetyl-p-aminophenol, APAP · CAS 103-90-2

APIs USP / EP / BP / CP CEPUSDMF Type IVCoA per batchSDS

Paracetamol is the highest-volume analgesic API in the catalogue and the one buyers qualify most carefully, because a single out-of-spec batch stops a tablet line. We supply pharmacopoeial grade material with per-batch CoA covering assay, 4-aminophenol, related substances and residual solvents, plus a nitrosamine risk assessment for EU and US customers.

Two manufacturing routes are available — phenol-based and p-aminophenol-based — and we declare which one a batch came from, because it changes the impurity profile your dossier has to defend. Particle size distribution can be adjusted for direct compression on request.

Identity

Catalogue no.BP-API-019
CAS number103-90-2
Molecular formulaC8H9NO2
Molecular weight151.16 g/mol
HS code2924.29
SynonymsAcetaminophen, N-Acetyl-p-aminophenol, APAP
Product lineActive Pharmaceutical Ingredients
CategoryAnalgesic & Anti-inflammatory

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
Assay99.0–101.0% (HPLC, on dried basis)
Related substances4-aminophenol ≤ 50 ppm; any unspecified impurity ≤ 0.10%
Total impuritiesTotal impurities ≤ 0.50%
Loss on dryingLoss on drying ≤ 0.5%
Residue on ignitionResidue on ignition ≤ 0.1%
Heavy metalsHeavy metals ≤ 20 ppm
Melting range168–172 °C
Particle sizeD50 20–60 µm (tunable)
Bulk density0.35–0.55 g/mL

Application

Analgesic and antipyretic formulations — tablets, granules, oral suspensions and suppositories.

Packaging, storage & logistics

Standard packaging25 kg fibre drum with double PE liner; 500 kg jumbo bag on request
Minimum order25 kg
Lead time7–15 days ex-stock; 25–30 days for campaign production
Storage conditionsStore below 30 °C, protected from light and 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

  • CEPCertificate of Suitability to the European Pharmacopoeia, issued by EDQM
  • USDMF Type IVOpen part available for excipient, colourant and packaging applications
  • CoA per batchBatch-specific, tested against the specification agreed at PO stage
  • SDSCurrent GHS revision; destination-language version on request
  • Nitrosamine risk statementRoute-based risk assessment plus batch nitrite data where applicable

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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