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Send us Fan Mail 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 calculati…

The J Value

Send us Fan Mail 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…
Send us Fan Mail 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…
Send us Fan Mail 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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