Diclofenac Desacetate Impurity, chemically identified as N-(2,6-Dichlorophenyl)aniline and also known as 2,6-Dichlorodiphenylamine, is the diarylamine core of Diclofenac lacking the acetic acid side chain, with molecular formula C₁₂H₉Cl₂N and molecular weight 238.11 g/mol. This compound is the key starting material of the classical Diclofenac synthesis, in which it is N-acylated with chloroacetyl chloride and cyclized to the indolin-2-one intermediate (Diclofenac EP Impurity A) before hydrolytic ring opening to the parent NSAID. Its presence in the API therefore reflects unreacted starting-material carryover, making it an important reference marker for starting-material control, synthetic-route purity, and process-related impurity profiling during Diclofenac manufacturing. Produced at Chemicea under tightly controlled synthetic and purification conditions, this reference standard supports impurity identification, analytical method validation (AMV), and quality-control testing of Diclofenac Sodium and Diclofenac Potassium in line with ICH Q3A/Q3B impurity requirements, and is routinely applied 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 quality-control laboratories worldwide. CAS No. 15307-93-4 | Explore complete technical documentation, Safety Data Sheet (SDS), and pricing.
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