<233> Elemental Impurities—Procedures

Type of Posting: Notice of Adoption of Harmonized Standard  
Posting Date: 25-Apr-2025  
Official Date: 01-May-2026  
Expert Committee: General Chapters–Chemical Analysis (GCCA)  
Coordinating Pharmacopeia: United States Pharmacopeia  

The new harmonized standard for 〈233〉Elemental Impurities—Procedures has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 4 of the PDG process, the 〈233〉 Elemental Impurities—Procedures chapter has been formally approved by the USP General Chapters—Chemical Analysis Expert Committee in accordance with the Rules and Procedures of the Council of Experts. 

Changes from the existing USP–NF monograph include: 

  1. The statement that this general chapter has been harmonized with the corresponding texts of the European Pharmacopoeia, the Japanese Pharmacopoeia, and/or the Indian Pharmacopoeia
  2. The “Use of Alternative Procedure” section is deleted, and new information was added in the introduction stating that the chapter permits the use of any procedure that meets the validation criteria specified in this chapter
  3. Sample Preparation subsection has been removed from the Procedures section and included under the introduction since it is applicable to user validated procedure in addition to Procedure 1 and 2 included in the chapter.
  4. The section title “Requirements for Alternate Procedure Validation” has been changed to “Requirements for Procedure Validation” and the section content has been revised.
  5. The section title “Limit Procedures” has been changed to “Procedures for Limit Tests” and the section content has been revised.
  6. The section title “Quantitative Procedures” has been changed to “Procedures for Quantitative Tests” and the section content has been revised.
  7. The revision incorporates application of the concepts of the ICH Q3D Guideline, which includes appropriate limits for specific elemental impurities together with a process for their assessment and control, that promote the development of individual monographs with aligned requirements for elemental impurities among the regions of the PDG pharmacopoeias.
  8. The revision incorporates updated requirements described in the ICH Q3D Guideline 

 

General Chapter <233> Elemental Impurities—Procedures was published on April 25, 2025, and will become official on May 1, 2026. 

Should you have any questions about this General Chapter, please contact Edmond Biba (301-230-3270 or exb@usp.org). For any questions about the PDG and its processes, please contact Richard Lew at (240-221-2060 or rll@usp.org).