病例历史-杂质控制-有效药物成分的关键问题

JOJ Sciences Pub Date : 2018-07-30 DOI:10.19080/jojs.2018.01.555566

Krishnasarma Pathy

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引用次数: 0

摘要

ICH杂质指南明确定义了有毒杂质的水平，并已成为建立药品杂质的基准。本文概述了杂质谱分析的概念，并介绍了通过网络购买的枸橼酸西地那非中活性药物成分和杂质定量的杂质谱分析及其相关结果。

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Case History-The Control of Impurities-A Critical Issue to The Active Pharmaceutical Ingredient

The ICH guidelines on impurity have clearly defined the levels of toxic impurities and have become benchmark in establishing impurities in pharmaceutical drug products. The present article summarizes the concept of impurity profiling and presents a case study on impurity profiling of quantification of active pharmaceutical ingredient and impurities in sildenafil citrate purchased via internet and its relative outcomes.

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JOJ Sciences

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