FDA, the US Drug Regulator, Publishes Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 13: Bulk Density and Tapped Density of Powders General Chapter
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This annex is the result of the Q4B process for the Bulk Density and Tapped Density of Powders General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Analytical Procedures
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. 2.9.34. Bulk Density and Tapped Density of Powders, JP 3.01 Determination of Bulk and Tapped Densities, and USP General Chapter Bulk Density and Tapped Density of Powders, can be used as interchangeable in the ICH regions subject to the following conditions:
- For Bulk Density Method 2, the tolerance of the cup volume should be 16.39 ±0.20 milliliters (mL).
- For Tapped Density Method 3, the test conditions, including tapping height,should be specified in the results.
- For Measures of Powder Compressibility, if V10 is used, it should be clearly stated in the results.
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