Studying Unidentified Impurities in Drug Substances by the Application of Multivariate (Principal Component and Cluster) Analysis

Quality Engineering vol. 16 issue 3 - March 2004

Abstract: [This abstract is based on the authors' abstract.] A drug impurity profile identifying both identified and unidentified impurities in a drug substance may be used to identify a particular drug and its associated method of manufacture. Determination of the chemical structure of any unidentified impurity is an important control factor in the manufacturing process, but may not be technically or economically feasible. A case study carried out in a bulk chemical plant illustrates how the application of multivariate analysis (principal component and hierarchical cluster analysis) is used to detect underlying structures among impurities making up the impurity profile of a drug substance. These underlying structures suggest the origin of the unidentified impurities.

Keywords: Case study - Chemical and process industries - Cluster analysis - Principal components - Multivariate analysis - Pharmaceutical industry - Manufacturing process

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