The Changing Landscape of Metals Testing for the Pharmaceutical Industry
- Date: Thursday December 6, 2012
- Time: 3pm UK / 4 pm CET / 10am EST
The US Pharmacopeia (USP) standards, <232> Elemental Impurities – Limits and <233> Elemental Impurities – Procedures, outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure. The new standards expand upon and will eventually replace USP standard <231>, which sets limits for the presence of heavy metals in active pharmaceutical ingredients and excipients. The standards were originally on track to become official on 1 December 2012, but postponement in November has been made. The enforcement of the standards will be delayed until 1 May 2014.
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