Bench Boost by Inorganic Ventures
Join our host and Inorganic Ventures Technical Director, Mike Booth, as he sparks insightful conversations with our panel of experts in Bench Boost, your go-to podcast for analytical chemistry enthusiasts. Together, they explore the realm of ICP, sharing tips and tricks and diving deep into all things analytical chemistry.
Bench Boost by Inorganic Ventures
Pharma Elemental Analysis Overview
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This week Mike & Ashley review the standardized methods for elemental impurity analysis in pharmaceuticals: ICH Q3D, USP <232>, and USP <233>. ICH Q3D provides guidelines for testing up to 24 elements and emphasizes risk assessment but not detailed testing calculations; USP <232> sets elemental impurity limits; and USP <233> addresses sample preparation and analysis and relies on ICH Q3D concepts such as “J” concentrations (to be covered next week). They explain risk assessment factors (element, route of administration, intentional addition, and screened materials) and outline element classes. They also discuss sample types (APIs, drug products, excipients) and how early screening can reduce final testing needs.
