ICH Q4B Annex 7 Dissolution test - Scientific guideline

This annex is the result of the Q4B process for the Dissolution Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). It aims to facilitate the recognition of pharmacopoeial dissolution test procedures by regulatory authorities in the ICH regions. It lists special conditions for which dissolution test cannot be considered as interchangeable in the ICH regions.

Keywords: Dissolution test, solid dosage form, pharmacopoeia, basket apparatus (apparatus 1), paddle apparatus (apparatus 2), flow-through cell, validation

Current effective version

ICH guideline Q4B annex 7 (R2) to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test - general chapter - Step 5

Adopted Reference Number: EMA/CHMP/ICH/645469/2008 Legal effective date: 01/05/2010

Document history - First version (current)

ICH guideline Q4B annex 7 (R2) to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test - general chapter - Step 5

Adopted Reference Number: EMA/CHMP/ICH/645469/2008 Legal effective date: 01/05/2010

ICH: Q 4 B Annex 7: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test general chapter - Step 3

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/645469/2008