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The management and technical evaluation requirements of chemical drug substances

The management and technical evaluation requirements of chemical drug substances. Huo Xiumin. State Food and Drug Administration Center for Drug Evaluation March 2010. I. Drug substance management of SFDA II. The information requirements and the main points of evaluation of CMC

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485 views • 31 slides

USP <467> Residual Solvents and VICH GL 18

USP <467> Residual Solvents and VICH GL 18. CVM/GADA Quarterly Meeting January 15, 2008. Talk Outline. Background on USP <467> and VICH GL 18 Information to be provided by manufacturers of APIs and Excipients Information to be provided in ANADAs.

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1.89k views • 29 slides

Lecture 6a

Lecture 6a. T h i n L a y e r C h r o m a t o g r a p h y. Introduction I. Chromatography was discovered by Russian botanist Mikhail Semyonovich Tsvett , who separated plant pigments using calcium carbonate columns (1901)

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284 views • 12 slides

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Solvent level - PowerPoint PPT Presentation

The management and technical evaluation requirements of chemical drug substances

USP &lt;467&gt; Residual Solvents and VICH GL 18

Lecture 6a

USP <467> Residual Solvents and VICH GL 18