A Review on N-nitrosamine Impurity

Author:

Pal Debangana1ORCID,B. Babu1

Affiliation:

1. Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, India

Abstract

Abstract: Nitrosamines are a category of substances that have a nitroso group linked to an amino group in their molecular structure. They are a category of carcinogens developed as a by-product of drug synthesis and also constituted in the presence of sodium nitrite or nitric acid and secondary amines (like dimethyl amines and diethyl amine) that must be monitored in drug production. In mid-June 2018, the Food and Drug Administration and the European Medicines Agency became aware of the existence of an impurity called N-nitrosamine in some frequently used medications, such as those for blood pressure, antacids, and diabetes. N-nitrosamines are of major concern because the ICH M7 (R1)2 guideline categorizes them as Class 1 impurities or mutagenic carcinogens, and the International Agency for Cancer Research categorizes them as potential carcinogens. The existence of N-nitrosamines in pharmaceutical drugs must be minimized to the greatest extent possible and must be at or below the threshold based on ICH M7(R1)2 fundamentals for materials in the "cohort of concern" described in this guideline and measured based on lifetime constant exposure.

Publisher

Bentham Science Publishers Ltd.

Reference76 articles.

1. Bharate S.; Critical analysis of drug product recalls due to nitrosamine impurities. J Med Chem 2021,64,2923-2936

2. Control of nitrosamine impurities in human drugs: Guidance for industry, U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER). Available from: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/control2020

3. Parr M.K.; Joseph J.F.; NDMA impurity in valsartan and other pharmaceutical products: Analytical methods for the determination of N-nitrosamines. J Pharm Biomed Anal 2019,164,536-549

4. GC/MS headspace method for detection of NDMA in valsartan drug substance US Food and Drug Administration Available from: https://www.fda.gov/downloads/Drugs/Drug Safety/UCM618053.pdf2019

5. Seyler T.H.; Kim J.G.; Hodgson J.A.; Cowan E.A.; Blount B.C.; Wang L.; Quantitation of urinary volatile nitrosamines from exposure to tobacco smoke. J Anal Toxicol 2013,37(4),195-202

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