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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.
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Estados Unidos
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The Inorganic Ventures team answers listener questions focused on pharmaceutical elemental impurity analysis by ICP-MS. They explain why an indium internal standard becomes unstable in high-pH matrices due to insoluble hydroxide formation and how EDTA complexation can stabilize ind…
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This week Mike and Ashley explain the J value used in pharmaceutical elemental impurity testing to relate typical ICP concentration units to permitted daily exposure (PDE) limits reported in micrograms per day under USP <232> and ICH Q3D. They describe how J value accounts fo…
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The Inorganic Ventures team members answer more listener questions relevant to trace analysis. They address low mercury recovery at 2 ppb, noting mercury instability in nitric acid, adsorption to plastic, options such as preparing in HCl or stabilizing with ~1 ppm gold. They explai…
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This week on Bench Boost Mike shares practical tips for analyzing pharmaceutical samples at low concentrations for USP 232 elemental impurities, emphasizing that high dilution makes small contamination or carryover issues critical. He advises minimizing contamination through carefu…
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