Determination of Extractable and Leachable Elements Using ICP-MS

E&Ls can enter a drug product during manufacturing, storage, and from the packaging system. The packaging components (those in contact with the drug product) can contain organic and inorganic E&L contaminants present a risk due to their inherent toxicity, while other compounds may adversely affect the efficacy, stability, and shelf-life of the drug.

We will share an E&L study that shows both the potential for the drug product to become contaminated under extreme conditions (extractables), and the actual contamination that occurs during normal and extended storage (leachables).

Presenter: L. Craig Jones (ICP-MS Application Scientist, Agilent Technologies, Inc.)

Craig has been with Agilent for over 15 years as an ICP-MS applications scientist. He has been involved with multiple type of applications for ICP-MS, including environmental, pharmaceutical, semiconductor, geologic, and clinical analyses, to name a few. Previous to Agilent he worked in an environmental lab performing analysis and supervising both the inorganic and organic sections of the laboratory. In his spare time, Craig enjoys volunteering at the local marine science center, mountain biking, hiking, and relaxing at the beach. Craig obtained a Bachelor of Science degree in chemistry from Fort Lewis College in Durango, CO.

Presenter: Jenny Nelson, PhD (Application Scientist, Agilent Technologies, Inc.)

Dr. Jenny Nelson is an Applications Scientist with Agilent Technologies specializing in Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), Microwave Plasma Atomic Emission Spectroscopy (MP-AES). Her broad knowledge of atomic spectroscopy has been applied to both AOAC and ASTM through her serving on expert review panels, chairing committees, and volunteering to develop new methods needed by the industry.