Current Trends and Glimpse for All Pharma Global Regulatory Agencies Requirements of Nitrosamine and NDSRIs Impurities in Pharmaceuticals
Journal Title: Der Pharma Chemica - Year 2024, Vol 16, Issue 2
Abstract
The USFDA and EMEA announced in July 2018 that N-Nitroso Dimethylamine and N-N-NDMA are concentrated on pharmaceutical medicinal products and specifically used in case of SARTANS that are used in the treatment of hypertension and angiotensin II receptor blockers, bringing the seriousness of nitrosamine presence to light. Subsequently, the diabetes medication pioglitazone and the histamine-2 blocker ranitidine were added to the list. Nitrosamines are created when amines, secondary amide carbamates and urea derivatives react with nitrates and nitrogenous agents. Nitrogen is at an oxidation state of +3. Pharmaceutical product degradation, catalysts, solvents, chemical reagents, cross-contamination, the manufacturing process and raw material contamination are some of the causes of nitrosamine presence in pharmaceutical products. Nitrosamine Impurity is detected using technologies such as gas chromatography, mass spectroscopy and light chromatography mass spectroscopy. According to ICH recommendations, N-nitrosamines are classified as a "cohort of concern" because they may be carcinogen and mutagen. The natural world. Class 2A human substances include N-nitroso dimethylamine and N-nitroso diethylamine. The possibility of N-nitrosamine contaminants in pharmaceutical goods poses a problem for the control of medical product quality. N-nitrosamines are regarded as substances of concern since many of the structurally straightforward molecules in this class have strong carcinogenic properties.
Authors and Affiliations
Rashid Azeez, Kalyani Bhor and Vinod A Bairagi
Keywords
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- EP ID EP742508
- DOI 10.4172/0975- 413X.16.2.263-273
- Views 16
- Downloads 0
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