Diclofenac EP Impurity D, chemically identified as 2-[2-[(2-Bromo-6-chlorophenyl)amino]phenyl]acetic acid and also recognized as the Diclofenac Bromo Analog, is a halogen-substituted diarylamine impurity of Diclofenac, with molecular formula C₁₄H₁₁BrClNO₂ and molecular weight 340.60 g/mol. Structurally, it differs from the parent NSAID by a bromine atom in place of one of the two ortho-chlorine atoms on the anilino ring. This impurity is typically traced to 2-bromo-6-chloroaniline present as a contaminant in the 2,6-dichloroaniline starting material, which is then carried through the diarylamine-forming and subsequent synthetic steps. Owing to this origin, the compound serves as an important process-related impurity marker for evaluating starting-material quality and synthetic-route control across Diclofenac Sodium and Diclofenac Potassium production. Manufactured at Chemicea under precisely controlled synthetic and analytical protocols, this reference standard supports impurity identification, method validation (AMV), and quality-control testing in accordance with EP and BP monograph 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 QC laboratories. CAS No. 127792-23-8 (sodium salt CAS No. 127792-45-4) | Explore complete technical documentation, Safety Data Sheet (SDS), and pricing.

Diclofenac EP Impurity D

CAT. No. CP-D20004
CAS. No. 127792-23-8
Mol. F. C14H11BrClNO2
Mol. Wt. 340.6
Stock Status In Stock
Rel. Cas No 127792-45-4 (Na salt)
Sample PDF VIEW COA Sample PDF VIEW MSDS
  • Category: Impurity Standards
  • Synonyms: [2-[(2-Bromo-6-chlorophenyl)amino]phenyl]acetic acid (as per EP)
  • Chemical Name: 2-(2-((2-Bromo-6-chlorophenyl)amino)phenyl)acetic acid

FAQ

Diclofenac EP Impurity D is an impurity that can occur in Diclofenac formulations due to specific synthesis or storage conditions.

Regulatory bodies require monitoring impurities like Diclofenac EP Impurity D to ensure the safety and efficacy of Diclofenac formulations.

It forms as a by-product under specific conditions such as temperature or pH variations during synthesis or storage.

Proper storage conditions and regular quality checks help minimize the formation of this impurity.

GC-MS, LC-MS, and HPLC-MS are commonly used methods for accurate detection and profiling of Diclofenac EP Impurity D.

Chemicea provides COA, H-NMR, MASS, HPLC, and TGA reports as standard, with additional reports like CNMR, IR, UV, DEPT, Water content, and CHNS available upon request.

Yes, Chemicea’s documentation meets the standards required by major regulatory agencies such as USFDA, EMA, ANVISA, TGA, and PMDA.

It is stable for shipping at room temperature, with specific storage guidelines provided in the COA.

Yes, Chemicea offers both standard and customized pack sizes to meet specific client requirements.

Chemicea supplies Diclofenac EP Impurity D as a reference standard, supporting regulatory compliance, method validation, and impurity profiling in Diclofenac formulations.

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