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Organic impurities in medicines ? new suggestions on USP general chapters

Date:14 May 2014

The same happened in Europe when EMA adopted ICH rules for generic drug substances and medicines in 2004 already. The European Pharmacopoeia has long addressed this issue with the creation of the so-called ?new monographs?. The changes, once officially applied, will lead to further testing on impurities apart from the monographs. For this ex-compendial testing, the use of pharmacopoeial reference standards is quite restricted, and connected for the user with some disadvantages.

LGC Standards provides its own range of impurity reference standards, which are accompanied by a detailed certificate of analysis and an attractive ratio on value for money. These standards are better suited than pharmacopoeial materials whenever the boundaries of the official monographs have to be left.

Click here to find out more on pharmaceutical impurities by LGC, or watch our recorded webinars on impurities.

To view USP general chapters <1086> and <476> and the associated stimuli article, click here.

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