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USP <232>/<233> Elemental Impurities

The USP has approved General Chapters <232> and <233>, Elemental Impurities. The intent of the new chapters is to provide safer products by utilizing newer technology. All drug products produced and/or sold in the United States will have to comply with the limits set by USP <232>. The new General Chapter recommends limits based on toxicity and exposure levels for these elements. The implementation of these chapters will replace USP <231>, Heavy Metals, which lacks sensitivity, specificity, and recovery to properly monitor the levels of these elements. Robertson Microlit performs the new method by inductively coupled plasma (ICP) instrumentation and has been performing analyses using this instrumentation for over 15 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 is able to follow the ICH Q3D Guidelines as well as the USP Guidelines. 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.

Elemental Impurities List

4 Required Elements: As, Cd, Hg, Pb

Class 1: As, Cd, Hg, Pb

Class 2A: Co, V, Ni

Class 2B: Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt

Class 3: Li, Sb, Ba, Mo, Cu, Sn, Cr

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.