Elemental Impurities: USP announces the Date of Entry into Force of Chapters <232> and <2232>

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20/21 September 2022

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On 14 January 2015 - just 2 days after the adoption of the "Guideline for elemental impurities - Q3D" by the CHMP - the USP announced the date for the validity of the General Chapters <232> (Elemental Impurities - Limits) and <2232> (Elemental Contaminants in Dietary Supplements).

Both chapters will be applicable as of January, 1st 2018. This date chosen by USP smoothly follows the date of implementation of the "ICH guideline Q3D on elemental impurities" in the European Member States (1st December 2017). At the same time, the USP published a so-called "Notice of Intent to Revise" which announces the revision of the "General Notices section 5.60.30". In these "General Notices" - which formally set the date for the implementation - you can still find the 1st December 2015, whereas the revised version has included the 1st January 2018. Moreover - according to another "Notice of Intent to Revise" - the abrogation of General Chapter <231> (Heavy Metals) will also be postponed from December, 1st 2015 to January, 1st 2018. Thus, the industry is given the opportunity to keep using this Chapter <231> and the numerous referenced monographs until the deadline on January, 1st 2018.

Further information can be found in a FAQ document about the Chapters <232>, <233> and <2232>. The justification for USP's approach with regard to the revision of the chapters is described in another FAQ document entitled "Rationale for USP's Proposed Standards for Elemental Impurities".