Analysis of large molecules like biopharmaceuticals and non-volatile pharmaceuticals can be problematic using thermal desorption or GC-injector sample introduction methods with current IMS-based CV equipment.  The new ESI-IMS instrument can analyze volatile, non-volatile, and thermally liable active ingredients at-line, producing data with great correlation to common analytical laboratory analysis by LC-MS.  It can achieve sub-nanogram limits-of-detection in milliseconds to seconds. Various top-selling commercial pharmaceutical drugs, including Risperidone, Paclitaxel, Erythromycin, Irinotecan, Vancomycin, Fluticasone, Clopidogrel, Simvastatin, Lansoprazole, and Insulin, were studied. 

Electrospray ionization: Ion mobility spectrometer (ESI-IMS) for cleaning validation (CV) in pharmaceutical manufacturing

240th National Meeting (2010)

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