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USP <232>/<233> Elemental Impurities

The USP has announced the approval of General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements with an official date of December 1, 2015. The intent of the new chapters is to provide safer products by utilizing newer technology. The implementation of General Chapters <232> and <233> also will include removal of all references to General Chapter <231> Heavy Metals from monographs and general chapters in the USP-NF 33 with an official date of December 1, 2015.

All drug products produced and sold in the U.S. will have to comply with the limits set by USP <232>. The proposed new General Chapter recommends limits based on toxicity and exposure levels for these elements. Drug substances and excipients will have to be tested and reported for elemental impurities, and although the control of impurities may be certified by a vendor, purchasers must also corroborate the absence of impurities before using materials in a manufactured article. Likewise, all nutraceutical products will have to comply with the limits set by USP <2232>.

Because USP <231>, Heavy Metals, lacks sensitivity, specificity, and recovery to properly monitor the levels of these elements, the new measures have been proposed and will soon be implemented. Robertson Microlit is currently performing USP <231>, Heavy Metals, and USP <232>/<233>, Elemental Impurities while transitioning its clients to the new Elemental Impurities method at comparable cost and turnaround. Robertson Microlit performs the new method by inductively coupled plasma (ICP) instrumentation and has been performing analyses using this instrumentation for over 10 years. RML utilizes this technology along with microwave digestion in order to provide better precision and yield higher recoveries.

If you would like to ensure that your material meets the new requirements, please contact us today for an evaluation. RML may be able to perform semi-quantitative screening or quantitative screening based on your choosing. RML also provides method development and validation services upon request. Please feel free to contact us for a quote, view our Sample Requirements and USP <232>/<233> Request Form.

Please refer to elements required by the new method below:

4 Required Elements: As, Cd, Hg, Pb

11 Remaining Table 1 Elements: Cr, Cu, Ir, Mo, Ni, Os, Pd, Pt, Ru, Rh, V

Other: Screening will also be required for all toxic metals that have been shown to be present, regardless of whether or not they are included in the impurities list.