ICH Q4B Annex 13 Bulk density and tapped density of powders - Scientific guideline

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. It aims to facilitate the recognition of pharmacopoeial bulk density and tapped density of powders procedures by regulatory authorities in the ICH regions.

Keywords: bulk density, tapped density, pharmacopoeia

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 13 to note for evaluation and recommendation of pharmacopoeial texts for use...

Reference Number: EMA/CHMP/ICH/405290/2010

Document history - First version (current)

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 13 to note for evaluation and recommendation of pharmacopoeial texts for use...

Reference Number: EMA/CHMP/ICH/405290/2010

ICH guideline Q4B: Annex 13 to Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders – General Chapter - Step 3

Draft: consultation closed Consultation dates: 24/09/2010 to 01/12/2010 Reference Number: EMA/CHMP/ICH/405290/2010 Legal effective date: 01/12/2010 Summary:

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).