Xceleron employs a range of quality control standards designed to characterize and control quantitative analytical LC + AMS methods. These are designed to control as follows:
The transfer of a LC or LC-MS/MS assay for use by LC+AMS entails significant changes and requires care followed by a full validation of the LC+AMS assay. Limited aspects of a previously validated LC or LC-MS/MS may be directly transferrable but insufficient testing of an LC+AMS method may introduce significant risk to the clinical study objectives and developmental timelines.
Xceleron routinely applies the following standards
Xceleron’s use of careful method transfer and three-batch validation has produced reproducible analytical methods that are accurate and precise.
Download our guide to transferring and validating quantitative analytical methods for LC+AMS here
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