LC-MS INSTRUMENT CALIBRATION - Harvard …

13. LC-MS INSTRUMENT CALIBRATION . FABIO GAROFOLO, Vicuron Pharmaceuticals, Inc. INTRODUCTION. As analytical and bioanalytical methods must be validated before using them for routine sample analysis and after changing method parameters (see Chapter 8), instruments such as liquid chromatography coupled with mass spectrometry (LC- MS) or tandem mass spectrometry ( LC-MS /MS), which are utilized to perform the analysis , should be calibrated and qualified. In addition, an INSTRUMENT 's per- formance should be tested for suitability prior to use on practically a day-to-day basis. For Good Laboratory Practice (GLP) studies, any equipment ( INSTRUMENT and any computer system used with it) must be tested according to the documented specifications. GLP regulations, which were issued by the Food and Drug Administration (FDA) in 1976, apply specifically to nonclinical studies used for Investigational New Drug (IND) registration.

200 LC-MS INSTRUMENT CALIBRATION compounds should be documented. LC-MS qualitative analysis always uses ref-erence materials, whereas quantitative analysis uses a combination of reference

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