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

Diclofenac Sodium

Sodium 2-[2-(2,6-dichloroanilino)phenyl]acetate · CAS 15307-79-6

APIs USP / EP / BP CoA per batchSDSGMP statement

A high-volume NSAID where the impurity profile matters more than the assay: the diclofenac lactam and the 2,6-dichloroaniline carry-over are what buyers test first. Both are controlled per lot and reported on the CoA.

Sits with the analgesic and anti-inflammatory line. Buyers in this group usually qualify two sources and split volume, so the documentation package and the released specification matter more than the price on the first order.

Identity

Catalogue no.BP-API-008
CAS number15307-79-6
Molecular formulaC14H10Cl2NNaO2
Molecular weight318.13 g/mol
HS code2922.49
SynonymsSodium 2-[2-(2,6-dichloroanilino)phenyl]acetate
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%
Related substancesLactam impurity ≤ 0.10%; 2,6-dichloroaniline ≤ 10 ppm; total impurities ≤ 0.5%
Water content≤ 0.5% (Karl Fischer)
Heavy metals≤ 20 ppm (ICP-MS)
Residual solventsComplies with ICH Q3C Option 1

Application

Enteric-coated tablets, sustained-release pellets, topical gels and injection concentrates.

Packaging, storage & logistics

Standard packaging25 kg fibre drum with double PE liner
Minimum order25 kg
Lead time15–25 days
Storage conditionsStore below 25 °C, protected from light and humidity
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

  • 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

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