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.