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Updated: May 9, 2025

A General Method for Detecting Nitrosamide Formation in the In Vitro Metabolism of Nitrosamines by Cytochrome P450s
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关于制药产品中N-尼托拉胺杂质的最新监管准则和分析方法的更新 - 2024年

Krishna Moorthy Manchuri1, Akhilesh Kumar Kuril2, Mahammad Ali Shaik1

  • 1Department of Chemistry, Jawaharlal Nehru Technological University Anantapur, Ananthapuramu, Andhra Pradesh, India.

Medical gas research
|April 29, 2025
PubMed
概括

控制制药中的N-尼托拉胺杂质是一个重大挑战. 本次审查涵盖了2024年至2024年的情况.

关键词:
含有N-尼托胺的杂质分析方法的分析方法.采用了尖端的分析技术.制药产品 制药产品 制药产品监管指南 监管指南

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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