MSACL 2017 EU Abstract

System Suitability Tests 3: Case Studies

Michael Wright (Presenter)
LGC, Drug Development Services

Bio: Mike is a principal scientist overseeing method development projects and driving scientific strategy for the Drug Development Services division at LGC. Over the past 17 years Mike has worked with quantitative HPLC and Mass Spectrometry services within CRO, hospital and university laboratory sectors both in the UK and in Australia. With a focus on biomarkers, he has been involved in the development of clinical assays for the fields of new-born screening, gastro-intestinal permeability, the investigation of metabolic disease, endocrinology and therapeutic drug monitoring.

Authorship: Mike Wright
LGC, Fordham, UK

Short Abstract

This talk will cover a series of "real world" case studies of LC-MS/MS assays where the system suitability test (SST) injection failed, or where it passed but the acceptance criteria had not been stringent enough. In each example the investigation will be walked through step by step: from the initial chromatograms, through to the troubleshooting process performed, the results from those experiments and the changes in processes that were introduced to prevent reoccurrence.

Long Abstract

References & Acknowledgements:

Financial Disclosure

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