Nitrosamine is the class of synthetic compound which is a potent genotoxic agent and considered as probable plausible human cancer-causing agent by international agency for research on cancer (IARC). Thus, N-nitroso compounds are known as potent carcinogenic and global worry according to the various authorities and also from ICH M7. Recently N-Nitrosodimethylamine (NDMA) has been detected in several pharmaceutical marketed drugs. These events have led regulatory agencies to require that N-nitrosamines risk assessments be performed on all marketed medical products. The need for these assessments is driven by the high carcinogenic potency of several N-nitrosamines in rodents, thus making these substances a significant regulatory concern. These impurities formed in drug products due to solvent, catalyst, raw materials are used in manufacturing process. Control of N-Nitroso drug substance related impurities is challenge for the pharmaceutical companies and regulatory agencies.