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标题：Euro analytica 2020 Pharmaceutical Impurity Analysis of Raw Materials and Final Product by using analytical techniques - Muhammad Jehangir - Novamed Pharmaceuticals.
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作者：Muhammad Jehangir
期刊名称：Journal of Research and Development
电子版ISSN：2311-3278
出版年度：2020
卷号：8
期号：2
页码：1-3
语种：English
出版社：OMICS International
摘要：“Isolation and identification of unknowncomponents and impurities” The evaluation ofpharmaceutical raw materials and finished productsfor impurities and degradation products is anessential part of the drug development andmanufacturing testing process. Additionally,toxicological information must be obtained on anydrug-related impurity that is present at aconcentration of greater than 0.1% of that of theactive pharmaceutical ingredient (API). Inpharmaceutical QC and manufacturing, impurityanalysis has traditionally been performed by HPLCwith UV, PDA, or MS detection. As it is essentialto detect and measure all of the impurities in thesample, it is necessary to have a high resolutionseparation process. This usually involves longanalysis times resulting in low throughput. Ascandidate pharmaceutical compounds becomemore potent and are dosed at lower and lowerlevels, ever more sensitive assays are needed todetect and measure impurities. The low throughputof HPLC can become the rate-limiting step inproduct release testing or process evaluation. Sincemuch of the process of impurity identificationinvolves the coupling of LC to sophisticated MS,any reduction in analysis time will result in a moreefficient use of these significant investments.Analytical technology advances such as UPLC andUPC offer significant improvements in throughputand sensitivity, with benefits to the process ofproduct release and identification of drug-relatedimpurities.
关键词：Pharmaceuticals; Testing; Stability;Materials