Diclofenac EP Impurity F, chemically defined as N-(4-Chlorophenyl)-2-(2,6-dichlorophenyl)acetamide and also recognized as Diclofenac USP Related Compound F or Diclofenac Acetamide, is a trichlorinated acetanilide-type impurity of Diclofenac, with molecular formula C₁₄H₁₀Cl₃NO and molecular weight 314.59 g/mol. Structurally, this compound differs from the diarylamine scaffold of the parent NSAID: the 2,6-dichlorophenyl ring is attached to the acetyl carbon, and the amide nitrogen carries a 4-chlorophenyl group. It is a process-related by-product associated with chlorinated aniline and 2,6-dichlorophenylacetic acid-type reagents or intermediates used in some Diclofenac synthetic routes. Owing to this structural profile, the compound serves as a reference marker for monitoring synthetic-route selectivity and chlorinated by-product control during API manufacturing. Manufactured at Chemicea under stringent synthetic and analytical protocols, this reference standard supports impurity identification, method validation (AMV), and quality-control testing in accordance with EP, BP, and USP requirements for Diclofenac Sodium and Diclofenac Potassium, and is routinely used in ANDA and DMF regulatory submissions. Each batch is supplied with a comprehensive Certificate of Analysis supported by HPLC, ¹H-NMR, and Mass Spectrometry characterization data, ensuring dependable analytical traceability for pharmaceutical R&D and QC laboratories. CAS No. 560075-65-2 | Explore complete technical documentation, Safety Data Sheet (SDS), and pricing.
Synonyms:
Diclofenac USP Related Compound F ; Diclofenac Acetamide (USP)
Chemical Name:
N-(4-Chlorophenyl)-2-(2,6-dichlorophenyl)acetamide
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