Request a quote
All products
Active Pharmaceutical IngredientsPharmaceutical IntermediatesVeterinary APIsPharmaceutical Packaging
Quality & compliance Resources About Contact
ENESFRRU
Request a quote

Fluconazole

2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol · CAS 86386-73-4

APIs USP / EP / BP CEPUSDMF Type IICoA per batchSDS

Fluconazole serves both oral solid and sterile IV presentations, and the two need different particle size windows — IV customers require a tighter D90 for dissolution of the concentrate. We release against the specification agreed at PO stage, not a single catalogue grade.

The triazole impurity profile is what regulators scrutinise. Our CoA lists each specified impurity against the EP monograph numbering, so your QA reviewer can cross-check without a translation table.

Identity

Catalogue no.BP-API-009
CAS number86386-73-4
Molecular formulaC13H12F2N6O
Molecular weight306.28 g/mol
HS code2933.99
Synonyms2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
Product lineActive Pharmaceutical Ingredients
CategoryAnti-infective

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% (HPLC, on dried basis)
Related substancesAny specified impurity ≤ 0.10%; unspecified ≤ 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 range137–141 °C
Particle sizeD90 ≤ 100 µm (IV grade on request)
Solution clarityComplies (EP)

Application

Antifungal capsules, tablets, oral suspension and IV formulations.

Packaging, storage & logistics

Standard packaging25 kg fibre drum with double PE liner
Minimum order25 kg
Lead time10–20 days
Storage conditionsStore below 30 °C, protected from light
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 IIOpen part available under confidentiality agreement for CMC review
  • CoA per batchBatch-specific, tested against the specification agreed at PO stage
  • SDSCurrent GHS revision; destination-language version on request
  • Particle size reportIssued with each lot on request.

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

Submitting opens your email client with these details filled in, so the enquiry reaches gm@bioranpharma.com directly. We use your details only to answer this enquiry — see privacy & data use.

Related products