ICH Q4B Annex 7 Dissolution test

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

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