Forced degradation studies of medroxyprogesterone acetate injectable suspensions (150 mg/ml) with implementation of HPLC, mass spectrometry, and QSAR techniques
Medroxyprogesterone acetate (MPA) injectable products are a key commodity for reproductive health and are available in the global market from a variety of manufacturing sources. Depending on the climatic zone conditions of the destination country for product use, MPA injectables are at risk of exposure to adverse transport and storage conditions. Analytical methods are available that quantify impurity levels in MPA and MPA injectable products, but minimal information is publicly available on the source of impurity and degradation product generation or the safety risk of these compounds. Forced degradation studies were conducted on MPA and MPA injectables to gain a better understanding of potential sources of impurities and degradation products. Furthermore, QSAR analysis was conducted to assess the toxicity risk of known impurities. More impurities were generated under acidic, basic, light, and oxidative forced degradation conditions relative to thermal degradation, however thermal exposure is the most likely adverse condition to be experienced by these products. Even if impurities are present in MPA injectables, QSAR analysis found that known impurities for MPA are apparently no more of a safety risk than MPA.
By David Jenkins, Christopher L. Harmon, Xiao Jia, Allen Kesselring, Danielle Hatcher, Katie Grayson, Jennifer Ayres