Drug Regulators, FDA, Publish Q4B Evaluation and Recommendations for Pharmacopeial Texts for use in ICH regions, Annex 12: Analytical Sieving General Chapter

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This annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.38. Particle-size Distribution Estimation by Analytical Sieving, JP 3.04 Particle Size Determination entitled Method 2. Analytical Sieving Method, and USP General Chapter Particle Size Distribution Estimation by 107 Analytical Sieving, can be used as interchangeable in the ICH regions.

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