Nitroso Impurities in Drug Products: An Overview of Risk Assessment, Regulatory Milieu, and Control Strategy

Author:

Charoo Naseem A.,Dharani Sathish,Khan Mansoor A.,Rahman ZiyaurORCID

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference67 articles.

1. U.S. Department of Health and Human Services. 14th report on carcinogens. https://ntp.niehs.nih.gov/whatwestudy/assessments/cancer/roc/index.html#toc1. 2017. Accessed December 1, 2020.

2. WHO-World Health Organization. Overall evaluations of carcinogenicity: an updating of IARC monographs volumes 1 to 42. Lyon (FR); 1987:7. https://monographs.iarc.who.int/wp-content/uploads/2018/06/Suppl7.pdf.

3. Schlingemann J, Burns MJ, et al. The landscape of potential small and drug substance related nitrosamines in pharmaceuticals. J Pharm Sci. 2022;S0022–3549(22):00525–31.

4. FDA-U.S. Food & Drug Administration. FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. Press Release. https://www.fda.gov/news-events/press-announcements/fdaannounces-voluntary-recall-several-medicines-containing-valsartan-followingdetection-impurity. 2018a. Accessed December 1, 2020.

5. FDA-U.S. Food & Drug Administration. FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products. Press Release. https://www.fda.gov/news-events/press-announcements/fda-provides-updateits-ongoing-investigation-valsartan-products-and-reports-finding-additional. 2018b. Accessed December 1, 2020.

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