ICH Q4B Annex 1 Residue on ignition/sulphated ash - Scientific guideline

This annex is the result of the Q4B process for Residue on Ignition/Sulphated Ash. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedure for the residue on ignition/suplhated ash test by regulatory authorities in the ICH regions. It describes special requirements for this test to be considered interchangeable for use in the ICH regions.

Keywords: Sulphated ash, residue on ignition, pharmacopoeia

Current effective version

ICH guideline Q4B Annex 1 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on residue on ignition/sulphated ash - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/222063/2006 Legal effective date: 01/06/2008

Document history - First version (current)

ICH guideline Q4B Annex 1 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on residue on ignition/sulphated ash - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/222063/2006 Legal effective date: 01/06/2008

ICH: Q 4 B Annex 1: Annex to regulatory acceptance of analytical procedures and/or acceptance criteria (RAAPAC) - Step 3

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/222063/2006