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Pharma Gets More Time to Control Elemental Impurities

This article was originally published in The Gold Sheet

Executive Summary

Delays in application of new USP and ICH limits on lead, mercury and other elemental impurities give industry more time to do the risk analysis and prepare to use new ICP-AES and ICP-MS test methods. The old heavy metals method was fine for yesterday’s lead-tainted water supply issues; the new methods are better for today’s global supply chain concerns.

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