N-Nitroso Diclofenac

N-Nitroso Diclofenac is a genotoxic nitrosamine impurity that can form in Diclofenac, a widely used nonsteroidal anti-inflammatory drug (NSAID), when nitrosating agents react with its secondary amine groups under acidic, oxidative, or other nitrosation-prone conditions. Chemically, it is described as 2-(2-((2,6-dichlorophenyl)(nitroso)amino)phenyl)acetic acid, also referred to as 2-[(2,6-dichlorophenyl)nitrosoamino]benzeneacetic acid, with a CAS No:66505-80-4; Molecular formula:C14H10Cl2N2O3; Molecular weight: 325.15 g/mol.

 As a structurally complex, non-volatile nitrosamine lacking specific experimental carcinogenicity data, it is considered potentially carcinogenic and genotoxic, and is classified under the US FDA Carcinogenic Potency Categorization Approach (CPCA) as Potency Category 5, carrying a default acceptable intake limit of 1500 ng/day, consistent with low-potency nitrosamines. The formation of N-Nitroso Diclofenac can occur during synthesis, from degradation of intermediate amines, or under improper storage in the presence of nitrite impurities, representing a high regulatory concern.

Manasa Life Sciences manufactures nitrosamine impurities in Hyderabad, India, and supplies products to markets across Asia, Europe, Africa, the GCC, and the UAE, ensuring reliable delivery, full traceability, and Good Documentation Practices (GDP) for nitrosamine impurities. And also we support complete nitrosamine-control readiness by supplying certified nitrosamine impurity reference standards, conducting in-depth risk assessments, and developing and validating ultra-sensitive LC-MS/MS and GC-MS analytical methods. Our solutions enable accurate detection, quantification, and control of nitrosamine impurities whether theoretical, synthesis-related, or degradation-derived helping manufacturers meet USP-relevant expectations, maintain strict global regulatory compliance, and safeguard patient safety.