Identifying and Evaluating Contamination Impurities

In the third case-study from his presentation at IVT's 9th Annual Method Validation and Development conference, Rafail Usatinsky explained the methodology for identifying and evaluating contamination impurities. A problem wherein small pieces of contaminant were found in an unstable intermediate. Through a multi-step investigation, Usatinsky led the audience through indentification the contaminant, determinination of the contaminant source, evaluation of the impact of the impurity on the intermediate and the active pharmaceutical ingredient (API), and determination the likelihood of contamination of other intermediate batches and API.

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