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Ibuprofen

2-(4-Isobutylphenyl)propionic acid · CAS 15687-27-1

APIs USP / EP / BP CEPUSDMF Type IVCoA per batchSDS

Ibuprofen is a racemic API where the enantiomeric ratio and the level of related substances decide whether a generic file clears review. Our material is supplied with chiral HPLC data and a full related-substances profile rather than a summary assay figure alone.

For softgel and suspension customers we can provide a milled grade with a tighter particle size window and a documented polymorph check, so the finished-product dissolution method does not need re-validation.

Identity

Catalogue no.BP-API-012
CAS number15687-27-1
Molecular formulaC13H18O2
Molecular weight206.28 g/mol
HS code2916.39
Synonyms2-(4-Isobutylphenyl)propionic acid
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
Assay98.5–101.0% (HPLC, on dried basis)
Related substancesAny individual impurity ≤ 0.10%; 4-isobutylacetophenone ≤ 0.10%
Total impuritiesTotal impurities ≤ 1.0%
Loss on dryingLoss on drying ≤ 0.5%
Residue on ignitionResidue on ignition ≤ 0.1%
Heavy metalsHeavy metals ≤ 20 ppm
Melting range75–77.5 °C
Optical rotation−0.05° to +0.05° (racemate check)
Particle sizeD90 ≤ 150 µm (standard)

Application

NSAID tablets, softgels, suspensions and topical gels.

Packaging, storage & logistics

Standard packaging25 kg fibre drum, double PE liner; 500 kg jumbo bag
Minimum order25 kg
Lead time7–12 days ex-stock
Storage conditionsStore below 30 °C in a dry place
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
  • Chiral purity dataEnantiomeric ratio by chiral HPLC

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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