USP issues Chapter "Elemental Impurities-Limits" for Comments

As you could already read in New Version of the ICH Q3D Guideline for Impurities published, the second revision of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) "Guideline for Elemental Impurities Q3D(R2)" has been finalised and is availalable on the ICH website under the "Quality Guidelines" section. As a result of this revision, the "<232> Elemental Impurities-Limits" chapter of the USP has now been revised and published for comments on the USP Pharmacopeial Forum website. Comments and remarks on this draft can be submitted until 31 January 2023.

Apart from formal changes, mainly adjustments and additions were made in the following sections and the associated tables:

  • Routes of Exposure 
  • Permitted Daily Exposures 
  • Recommendations for Elements to Be Considered in the Risk Assessment 
  • Drug Substance and Excipients

These four sections were extended by the items cutaneous (and transcutaneous) dosage forms, and the PDE values and concentrations for the corresponding elements (see Table 1 and Table 3) have been added. Similarly, adjustments were made to the PDE values of the elements gold, silver (parenteral administration) and nickel (inhalation administration) in Tables 1 and 3. Table 2 now also lists the item of cutaneous administration and the corresponding assessment of the elements with regard to the risk consideration.

The draft chapter "<232> Elemental Impurities-Limits" is available for comments after a one-time registration on the Pharmacopeial Forum website.

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