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USP Heavy Metal Chapter Revisions on the Way; New Screening Methods to be Implemented

May 31, 2012
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

The revised US Pharmacopeia revised chapters on elemental impurity limits and procedures ( and ) are set to become official by the end of the year, and companies are beginning to think about implementation, which will be required by May 2014 (see back story).

The revised US Pharmacopeia revised chapters on elemental impurity limits and procedures (<232> and <233>) are set to become official by the end of the year, and companies are beginning to think about implementation, which will be required by May 2014 (see back story).

According to the latest update from the USP website, the new chapters will be published in the Second Supplement to USP 35–NF 30 (official Dec. 1, 2012). Conformance with these chapters will be required by May 1, 2014. In the interim, all references to USP General Chapter <231> Heavy Metals will be removed from monographs in the compendia.

The International Conference on Harmonization (ICH) Working Group on Elemental Impurities is simultaneously working to develop a harmonized approach for controlling these impurities, including risk-assessment recommendations and safety limits for specific metals, that meet testing and regulatory filing requirements at the global level. USP has noted that its expert panel is not waiting for the final recommendations from the ICH Q3D Expert Working Group but does note that the limits in the new General Chapter <232>, except for mercury, are in line with those in the stage 2 draft of the Q3D guideline. “At a future date, the Expert Panel intends to revisit General Chapter <232> relative to the Step 4 outcome of ICH Q3D deliberations,” says the USP elemental impurities webpage.

PharmTech is hosting and moderating a free educational webinar about the revised USP chapters on June 14, 2012, with a specific focus on new testing procedures and practices for detecting elemental impurities. Instrumentation, key challenges, best practices, and will be addressed.

Register for the free webinar