Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
Vinod A Bairagi
Department of Pharmaceutical Quality Assurance, KBHSS Trust Institute of Pharmacy, Bhaygaon, Malegaon Camp, Malegaon Nashik, IndiaPublications
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Research Article
Current Trends and Glimpse for All Pharma Global Regulatory Agencies Requirements of Nitrosamine and NDSRIs Impurities in Pharmaceuticals
Author(s): Rashid Azeez*, Kalyani Bhor and Vinod A Bairagi
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 tec.. Read More»
DOI: 10.4172/0975- 413X.16.2.263-273
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