NDSRIs Crisis in Pharmaceuticals; Insights on Formation Pathways, Root Causes, Risk Management, and Novel Analytical Techniques.

Autor:	P R HV; Department of Pharmaceutical Chemistry, JSS College of Pharmacy, Mysuru, JSS academy of higher education and research (JSSAHER) - 570015, Karnataka, India., Kandula DR; Department of Pharmacy, Shri Jagdishprasad Jhabarmal Tibrewala University, Jhunjhunu- 333010, Rajasthan, India., Gunta U; Department of Biotechnology, Dravidian University, Kuppam- 517426, Andhra Pradesh, India., Kumar G; Xenone Healthcare Pvt. Ltd, #318, Third Floor, US Complex, Jasola, New Delhi-110076., Deka R; Department of Zoology, Bhattadev University, Pathsala, Bajali, Assam, India., Chiriki DS; Department of Pharmaceutical Chemistry, JSS College of Pharmacy, Mysuru, JSS academy of higher education and research (JSSAHER) - 570015, Karnataka, India., Chethan KS; Department of Pharmacology, JSS Academy of Higher Education and Research (JSS AHER), JSS College of Pharmacy, Mysuru, Karnataka, India., Bannimath N; Department of Pharmacology, University of Galway, University Road, Galway, Ireland-H91 TK33., Yadav T; Department of Pharmaceutical Chemistry, JSS College of Pharmacy, Mysuru, JSS academy of higher education and research (JSSAHER) - 570015, Karnataka, India., Beeraka NM; Department of Human Anatomy and Histology, I.M. Sechenov First Moscow State Medical University (Sechenov University), 8/2 Trubetskaya Street, Moscow, 119991, Russian Federation., Gurupadayya BM; Department of Pharmaceutical Chemistry, JSS College of Pharmacy, Mysuru, JSS academy of higher education and research (JSSAHER) - 570015, Karnataka, India.
Jazyk:	angličtina
Zdroj:	Current medicinal chemistry [Curr Med Chem] 2024 Sep 12. Date of Electronic Publication: 2024 Sep 12.
DOI:	10.2174/0109298673322023240829081220
Abstrakt:	The discovery of a new class of nitrosamine impurities called N-nitroso drug substance related impurities (NDSRIs) in pharmaceuticals has emerged as a significant challenge for the pharmaceutical sector due to their significant genotoxic and mutagenic effects. Regulatory bodies globally in active collaboration with all the concerned stake holders, are taking effective measures to prevent and control NDSRIs. This comprehensive review on NDSRIs discusses formation pathways, root cause analysis, acceptable intake limits, case studies, control strategies and regulatory responses pertaining to recent NDSRI incidents. This review discusses the novel liquid chromatographic techniques (LC- MS/MS, GC-MS/MS) used to identify and quantify of NDSRIs. This review would aid pharmaceutical professionals, R&D analytical and formulation scientists, and regulatory bodies in gaining deeper insights into the NDSRIs crisis, facilitating formulation of NDSRI-free drug products, and ensuring their sensitive detection with accurate risk evaluation. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)
Databáze:	MEDLINE
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