USP Defers Implementation of Elemental Impurities Provisions - Pharmaceutical Technology

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USP Defers Implementation of Elemental Impurities Provisions
USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.


In a compendial notice issued on May 24, 2013, the Chair of the USP Council of Experts, in consultation with the Executive Committee of the Council of Experts, has deferred proposed 5.60.30 Elemental Impurities in General Notices. This proposed revision suggested a May 1, 2014 date linking General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures to drug product monographs in the United States Pharmacopeia (USP).  As such, section 5.60.30 will not be included in the General Notices that will be published in USP 37–NF 32, and therefore there is no requirement for any drug product in the USPNF to comply with <232> and <233> at this time, said USP in the notice. The proposed omission of General Chapter <231> Heavy Metals also has been deferred. 

USP said these deferrals will allow USP to work closely with ICH Q3D to align its activities with the implementation of General Chapters <232> and <233>. The deferral also allows USP to work with those affected by the new elemental impurity standards.  In this regard, USP plans to form an Advisory Group on the Implementation of General Chapters <232> and <233>.

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