Comprehensive certification of a testosterone calibration standard facilitating the investigation of charged aerosol detection for the quantification of impurities of related structure

Abstract

Testosterone, an analyte of interest to medical testing laboratories, was purity assigned using a mass balance approach, to afford a certified value of 986 ± 3 mg g-1 with established metrological traceability to the SI unit for mass (kg). The gas chromatography with flame ionisation detection (GC-FID) analysis identified the thermal degradation of testosterone as a source of bias, and confirmed the other four impurities to be steroids of closely related structure through co-elution studies. Combined with measures of water, solvent and non-volatile residue the total purity was in agreement with that determined by the complementary quantitative NMR spectroscopy, providing a high level of conf..