Bioanalysis Zone

Interference from donor gender on long-term stability of etonogestrel in human plasma (inVentiv Health Clinical)

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Introduction:

Etonogestrel is the active metabolite of the inactive prodrug desogestrel, a steroidal progestin used in hormonal contraceptives. A bioanalytical study was performed for the determination of etonogestrel in human plasma from a clinical study. To cover the life of the study samples, the long-term stability (LTS) in human plasma of etonogestrel needed to be extended from 114 to 174 days at -20°C. However, LTS evaluation of 139, 183 and 196 days failed with %bias above 15% at the low concentration level for the stability samples.

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