Paper Title
Control strategy of Nitrosamine impurities in Pharmaceutical Drugs
Article Identifiers
Authors
Mr. Monik Gohil , Dr. Yogesh M. Baj
Keywords
N-Nitrosamines, Cohort of Concern, ICH M7, Drugs, exposure
Abstract
The carcinogenic properties of nitrosamines have been known for more than 50 years [1] and there are several nitrosamines that have been tested for carcinogenicity and have shown carcinogenic activities N-nitroso-dimethylamine (NDMA), N-nitroso-diethylamine (NDEA), N-nitroso-N-methyl-4-aminobutyric acid (NMBA), N-nitroso-diethanolamine (NDELA), nitroso-morpholine (NMOR), N-nitroso-N-methyl-N-ethylamine, and N-nitrosopyrrolidine (NPYR), being some of the well-known among these [2,3]. There are many more Nitrosamines are considered during the assessment as per ICH M7(R2), EMA guideline (current versions of EMA/369136/2020 & EMA/409815/2020) and Control of Nitrosamine Impurities in Human Drugs (Febuary-2021 Rev-1), as high potency mutagenic carcinogens referred to as compounds that are part of the “cohort of concern” and as such are classified as Class 1 impurities “known mutagenic carcinogens,” based on both rodent carcinogenicity and mutagenicity data [4]. In order to ensure that the presence of nitrosamine impurities in the medicinal products is mitigated as much as possible and controlled at or below a limit defined based on ICH M7(R2), EMA guideline (current versions of EMA/369136/2020 & EMA/409815/2020) and Control of Nitrosamine Impurities in Human Drugs (Febuary-2021 Rev-1). This review article reflects calculation for the control of nitrosamine impurities in drugs by considering lifetime daily exposure.
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How To Cite (APA)
Mr. Monik Gohil & Dr. Yogesh M. Baj (May-2023). Control strategy of Nitrosamine impurities in Pharmaceutical Drugs. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(5), j259-j264. https://ijnrd.org/papers/IJNRD2305949.pdf
Issue
Volume 8 Issue 5, May-2023
Pages : j259-j264
Other Publication Details
Paper Reg. ID: IJNRD_197890
Published Paper Id: IJNRD2305949
Downloads: 000121995
Research Area: Pharmacy
Country: Vadodara, Gujarat, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2305949.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2305949
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