WCPS: Analytical Workflow for Elemental Extractables and Leachables in reference to USP and ICH Guidelines: Intravenous Bag Case Study

Application Note Pharmaceuticals Determination of Extractable and Leachable Elements Using ICP-MS Analysis of elemental impurities from plastic ophthalmic drug containers using an Agilent 7900 ICP-MS Authors Paige Solomon University of California, San Francisco, CA, USA Jenny Nelson Agilent Technologies, Inc.…

Inductively Coupled Plasma Mass Spectrometer Application News ICPMS-2030 Extractables Analysis of Elements in Plastic Pharmaceutical Packaging Chiho Kiriyama, Aya Urushizaki, Tadashi Taniguchi, and Takahide Hiramatsu User Benefits  Extracted elements can be examined based on extractables and leachables (E&L) guidelines.…

The Doctor Did Not Prescribe Irgafos: A Solution for Extractables and Leachables Analysis The world leader in serving science Outline • Introduction • Why conduct Extractables & Leachable (E&L) analysis? • Industries need Extractable & Leachable analysis • Regulations and…

White Paper USP <232>/<233> and ICH Q3D Elemental Impurities Analysis: The Agilent ICP-MS Solution Elemental Impurity Analysis Requirements Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. Potentially toxic and harmful contaminants—including elemental impurities—must…