Within this seminar you will hear about:
The current regulatory requirements regarding metal impurities determination in various Pharmacopoeia (USP, EP, IP)
The various possibilities to approach the metal impurity determination
The reference material which Merck offers to help your analysis produce accurate results
Metal analyses have become increasingly important to the pharmaceutical industry in recent years. Pharmaceutical products can pick up metal contaminations such as arsenic, lead, cadmium or mercury from many different places. These metals may be present in the raw materials themselves, or enter during production as a result of syntheses or interactions with equipment.
This seminar gives an overview about the current regulatory requirement for various Pharmacopoeia and the ICH Q3D guidelines. It also explains various approaches to determine metal impurities and introduces the portfolio of the reference materials, Merck offers for the determination of these impurities.
About Ingrid Hayenga, PhD
Dr. Ingrid Hayenga is the Global Product Manager for Environmental Standards including pesticides and organic pollutants within the Merck's Advanced Analytical Reference Materials team, located in Buchs/Switzerland. She is responsible for introducing new analytical standard and certified reference materials to the market. Prior to this position she was a Senior R&D Chemist focusing on developing analytical standards for environmental and food & beverage applications and had several positions in R&D, Marketing and Quality Control.
She joined Sigma-Aldrich / Merck after completing her post-doctoral studies at the University of Edmonton, Canada and her PhD thesis in Münster, Germany.