Pharmaceutical Impurities: An Overview

被引：0
|
作者：
Rao, N. Rama [1 ]
Kiran, S. S. Mani [1 ]
Prasanthi, N. L. [1 ]
机构：
[1] Chalapathi Inst Pharmaceut Sci, Lam 522034, Guntur, India
来源：
INDIAN JOURNAL OF PHARMACEUTICAL EDUCATION AND RESEARCH | 2010年 / 44卷 / 03期
关键词：
Impurities; formulation; efficacy; degradation; IDENTIFICATION;
D O I：
暂无
中图分类号：
G40 [教育学];
学科分类号：
040101 ; 120403 ;
摘要：
The impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product. The control of impurities is currently a critical issue to the pharmaceutical industry. International Conference on Harmonization (ICH) formulated guidelines regarding the control of impurities. This review outlines the description of different types and origins of impurities and degradation routes with specific examples.
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收藏
页码：301 / 310
页数：9
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