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Real Time and Accelerated Stability Studies of Testosterone Calibrators

Authors: Linda Nagore, Ravi Orugunty, Isil Dilek, and Uma Sreenivasan
Presented at American Society for Mass Spectrometry (ASMS), San Antonio, TX, June 5-9, 2016

Abstract
Development of accuracy-based calibrators in biological matrices for clinical diagnostic applications requires reference measurement calibrators and materials with high accuracy and sensitivity. Testosterone presents a unique challenge with the wide range of endogenous levels across female, male and age-based patient populations. A method for quantitation of Testosterone across the entire therapeutic range from 20 pg/mL to 20,000 pg/mL in serum by Liquid Chromatography Mass Spectrometry (LC-MS/MS) was developed and validated. Given the 1000-fold range of the calibrators the analysis is divided into three groups. Data presented will provide evidence on the quality of the product and show that the Testosterone calibrators will remain stable under normal use and recommended storage conditions.

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