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USP has posted updates to USP General Chapter <232> Elemental Impurities. This chapter is being revised to address comments received and to further align this chapter with ICH Q3D. USP’s Elemental Impurities Expert Panel approved a recommendation to the General Chapters—Chemical Analysis Expert Committee that this chapter be revised to align with the ICH Q3D Step 4 document to the greatest extent possible. Therefore, this revision is being proposed to include additional elements and their specific limits in this chapter. Additional changes are made to provide clarity on the topic of risk assessment. Stakeholders are encouraged to comment only on the revised text. Additionally, minor editorial changes have been made to update the chapter to current USP style.
Industry has requested USP align with ICH Q3D and clarify the excipient information. The proposed revisions will appear in PF March- April and comments can be submitted until May 30, 2016. The changes will be discussed at the IOEC- CRM March 3 meeting.
