Dr. Mounier-Lee will detail how a UPLC method was developed and validated for simultaneous quantitation of related substances in a combination drug product containing two active pharmaceutical ingredients (APIs). The method was then shown to separate the four known degradation products as well as API-related impurities and unknown related substances. This enhanced UPLC method allows for more reliable and efficient testing of the product relative to the current state in which testing was conducted via two separate HPLC methods.
Dr. Mounier-Lee received her B.S. in Chemistry from the Ecole Supérieure de Chimie Industrielle de Lyon, France, and her Ph.D. in Chemistry from Emory University in Atlanta, Georgia, USA, followed by a NIH postdoctoral research position at the Georgia Institute of Technology in Atlanta, Georgia, USA. She specializes in liquid chromatography, high-pressure liquid chromatography, gas chromatography, headspace analysis, and dissolution testing.
For more information on Catalent’s broad range of biopharmaceutical development, go to http://www.catalent.com/development.
About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,000 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more information, visit http://www.catalent.com.
Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Www.catalent.com.
