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