학술논문
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products.
Document Type
Academic Journal
Author
Akkaraju H; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, 576 104, India.; Tatia R; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, 576 104, India.; Mane SS; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Changsari, 781 101, India.; Khade AB; Department of Pharmaceutical Chemistry, Indira Institute of Pharmacy, Sadavali, Devrukh, Ratnagiri, Maharashtra, 415 804, India. Electronic address: abkhade@gmail.com.; Dengale SJ; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, 576 104, India; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Changsari, 781 101, India. Electronic address: swapnil@niperguwahati.in.
Source
Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE
Subject
Language
English
Abstract
N-nitrosamines are carcinogenic impurities most commonly found in groundwater, treated water, foods, beverages and consumer products. The recent discovery of N-nitrosamines in pharmaceutical products and subsequent recalls pose a significant health risk to patients. Initial investigation by the regulatory agency identified Active Pharmaceutical Ingredients (API) as a source of contamination. However, N-nitrosamine formation during API synthesis is a consequence of numerous factors like chemistry selection for synthesis, contaminated solvents and water. Furthermore, apart from API, N-nitrosamines have also been found to embed in the final product due to degradation during formulation processing or storage through contaminated excipients and printing inks. The landscape of N-nitrosamine contamination of pharmaceutical products is very complex and needs a comprehensive compilation of sources responsible for N-nitrosamine contamination of pharmaceutical products. Therefore, this review aims to extensively compile all the reported and plausible sources of nitrosamine impurities in pharmaceutical products. The topics like risk assessment and quantitative strategies to estimate nitrosamines in pharmaceutical products are out of the scope of this review.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Inc. All rights reserved.)