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GMP News

BP Publishes Key Insights on Chromatography and SST

The British Pharmacopoeia (BP) has published so-called “Key Insights” focusing on chromatography in the BP and selected system suitability test (SST) requirements described in the chapter “Chromatographic Separation Techniques”. The article covers system suitability requirements in Chromatographic Separation Techniques (CST), peak symmetry, and system sensitivity.

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How are Reference Standards used in the Pharmaceutical Industry?

The use of reference substances is a key component of pharmaceutical analysis and quality assurance. Reference substances (or reference standards) play a crucial role in ensuring the safety, harmlessness and efficacy of medicinal products. Find out more on how reference substances are used in the pharmaceutical industry.

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Endotoxin Test – Updated FDA Q&A document published

With the publication of a revised Q&A guide, the FDA is responding to the recommendations on endotoxin testing set out in USP chapters <85> and <161> and in the AAMI guidelines for medical devices.

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