Development of forced degradation and stability indicating studies of drugs-A review.
Development of forced degradation and stability indicating studies of drugs-A review.
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DOI：
10.1016/j.jpha.2013.09.003
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发表时间：
2014-06
影响因子：
8.8
通讯作者：
Agrawal YK
中科院分区：
文献类型：
--
作者：
Blessy M;Patel RD;Prajapati PN;Agrawal YK
强制降解是指新原料药和制剂在比加速条件更严格的条件下发生的降解。需要证明稳定性指示方法的专属性，并提供对原料药降解途径和降解产物的深入了解，并有助于阐明降解产物的结构。强制降解研究显示了分子的化学行为，这反过来又有助于配方和包装的开发。此外，监管指南非常笼统，没有解释强制降解研究的性能。因此，本文通过提供进行降解机制研究的策略，讨论了当前强制降解研究的发展趋势，并描述了有助于开发稳定性指示方法的分析方法。
Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation studies. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms and also describes the analytical methods helpful for development of stability indicating method.