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The comparison of batches of pharmaceutical product or raw active pharmaceutical ingredients (API) for product release can be time consuming and tedious process. It often requires long analysis times and potentially several liquid chromatography-tandem mass spectrometry (LC-MS-MS) analytical runs to determine the identity of the impurities and their relationship to the active pharmaceutical ingredient. The combination of a high resolution (sub 2 µm porous particle) LC coupled to exact mass MS, principal components analysis (PCA) allowed for the rapid classification of batches of Simvastatin tablets according to their impurity profile. Evaluating the ultra-performance LC-MS exact mass data with PCA allowed for the impurities of Simvastatin to be easily detected and identified. This approach to impurity batch analysis should be applicable to many other forms of batch analysis, fermentation broths, food production, and API manufacturing.

journal of chromatographic science

A Rapid Simple Approach to Screening Pharmaceutical Products Using Ultra-Performance LC Coupled to Time-of-Flight Mass Spectrometry and Pattern Recognition