There is increasing scrutiny on elemental impurities because of the potential high risk for interaction with drug products and the possible impact on safety and efficacy. Elemental impurities can come from many different sources, including the active pharmaceutical ingredient, excipients, the drug vehicle, and from leaching of elemental entities that are present in the drug product’s manufacturing and/or packaging systems. According to developing guidelines from the International Committee on Harmonization (ICH) and the US Pharmacopeia (USP), elemental impurities must be identified and managed to acceptable levels.1
1 Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: a Literature Review by Dennis R Jenke, Cheryl L.M. Stults, Diane M. Paskiet, et al. PDA J Pharm Sci and Tech 2015, 69 1-48.
VR Analytical's Risk-Based Approach
VR Analytical leverages its years of experience assessing risk, expertise in materials assessment, and a benchmark ICP-MS method against the pending requirements (USP <232> and <233> Elemental Impurities, and ICH Q3D Guideline on Elemental Impurities) to identify known and potential sources of elemental impurities that may find their way into a drug product.