EKG Labs is excited to share our first publication in the Journal of Pharmaceutical and Biomedical Analysis (Volume 187), published in collaboration with FHI 360. FHI 360 is an international nonprofit promoting lifesaving health care in over 60 countries. The paper, “Forced Degradation Studies of Medroxyprogesterone Acetate Injectable Suspensions (150 mg/ml) with Implementation of HPLC, Mass Spectrometry, and QSAR Techniques” features EKG authors Katie Grayson, Dr. Allen Kesselring, Dr. Xiao Jia, and Danielle Hatcher.
This publication is based on a forced degradation study on medroxyprogesterone acetate performed at EKG Labs a couple years ago. Medroxyprogesterone acetate (MPA) is a key drug for reproductive health. Particularly in the developing world, MPA and MPA injectable products may be at risk of exposure to adverse transport and storage conditions. The purpose of EKG’s study, performed on behalf of FHI, was to gain a better understanding of MPA impurities and degradation products. Forced degradations (acidic, basic, light, and oxidative conditions—relative to thermal degradation) were performed on a variety of MPA products, followed by LC/MS analysis.
EKG Labs routinely performs impurity identification studies such as this one. While much of EKG’s work is performed with a goal of helping our clients bring drug products or medical devices to market, we also enjoy partnering with groups looking to perform research studies with an end goal of publication.
The article can be accessed at https://doi.org/10.1016/j.jpba.2020.113352 or by clicking below.
About EKG Labs
EKG Labs is an analytical service provider for the medical device and pharmaceutical industries. In addition to performing forced degradation studies, our wide variety of analytical services support regulatory filings, product development, and analytical chemistry investigations.
Some of our other services include:
- Extractables and Leachables Analysis
- Impurity Identification
- Material/Chemical Characterization
- Method Development and Validation