Open AccessNitrosamine Impurities: Origin, Control and Regulatory Recommendations
Author(s) -
Umesh Dobariya,
Narendra Pal Singh Chauhan,
Himani Patel,
Nidhi Pardeshi
Publication year - 2021
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v9i2.472
Subject(s) - drug , nitrosamine , carcinogen , ranitidine , pharmacology , business , chemistry , risk analysis (engineering) , medicine , organic chemistry
The unexpected finding of presence of nitrosamine impurities, by USFDA and EMA in year 2018, in drugs such as Angiotensin-II Receptor Blockers (ARBs), Ranitidine, Nizatidine and Metformin, has triggered the need for a risk assessment strategy for evaluation and control of these probable human carcinogen - nitrosamine in pharmaceutical product that are at risk. This finding leads to voluntarily recall of products worldwide. The finding of nitrosamines in some types of drug products led FDA and other international regulators to conduct a detailed risk assessment of these impurities in APIs and drug products. Although nitrosamine impurities have been found in only some drug products, regulatory agencies recommended to extend risk analysis in other chemically synthesized APIs and drug products also.