Witryna16 maj 2011 · The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including … Witryna59 . product attributes Type of measured product attribute Analytical Procedure Performance Characteristics to be demonstrated (2) I. DENTITY. I. MPURITY …
Assuring quality of drugs by monitoring impurities - PubMed
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ICH guideline Q2(R2) on validation of analytical procedures
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