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Harmonization of Requirements Between ICH Q3D and Pharmacopeias Kahkashan Zaidi, USP. PQRI/USP Workshop on Elemental Impurities March 31 April 1, 2015. USP. Rockville, Maryland 20 year Journey Elemental Impurities To Heavy Metals Metals and Pharmacopeias: Where we started from: USP. <231> Heavy Metals 3 wet chemistry methods all involving Sulfide precipitation of metals Visual comparison to lead standards Heavy metals 8 wet chemistry methods JP. Heavy Metals Limit Test 4 wet chemistry methods USP Elemental Impurities-1995 to 2015. 1995 First stimuli article identified issues with <231> method II (K. Blake). 2000 Second stimuli article proposed ICP-MS as an instrumental alternative (T. Wang). 2004 Third Stimuli article by USP's PA6. EC recommended abandonment of the existing <231> for the first time . Elemental Impurities-1995 to 2015.
Harmonization of Requirements Between ICH Q3D and Pharmacopeias Kahkashan Zaidi, USP PQRI/USP Workshop on Elemental Impurities March 31 – April 1, 2015 USP Rockville, Maryland
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