The introduction of nitrosamine impurities in medicinal products

doi:10.5246/jcps.2023.03.020

Abstract

Abstract:

Nitrosamine impurities being reported to potentially present in medicinal products are the new hot issues in the pharmaceutical field during recent years. Five classes of medicinal products are being reported due to the possible presence of nitrosamine impurities: Sartan medicines, Metformin-containing medicines, Ranitidine medicines, Rifampicin medicines, and Champix. In this paper, we introduced the source and potential root causes of nitrosamine formation, potential or founded nitrosamine impurities in API and medicinal products, and acceptable intake limits recommended for those impurities. Moreover, we also summarized the current nitrosamine impurities concerned with medicinal products and corresponding control strategies adopted by the FDA and EMA, and it is expected to give reference for the Chinese or foreign pharmaceutical enterprises, as well as the regulatory authority, to get the comprehensive understanding of the nitrosamine impurities in the medicinal products.

Key words: Nitrosamine impurities, Medicinal product, Food and Drug Administration, European Medicines Agency, Active Pharmaceutical Ingredient

Supporting:

Jianzhao Niu, Dongsheng Yang, Yufei Feng, Baihao Sun, Haoyue Guan, Lingyun Ma. The introduction of nitrosamine impurities in medicinal products[J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(3): 223-230.

Figures/Tables 2

References 20

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