ICH Q4B Annex 2 Test for extractable volume in parenteral preparations - Scientific guideline

This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for the test for extractable volume of parenteral preparations by regulatory authorities in the ICH regions.

Keywords: Test for extractable volume of parenteral preparations, injections, pharmacopoeia

Current effective version

ICH guideline Q4B annex 2 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/559409/2007 Legal effective date: 01/12/2008

Document history - First version (current)

ICH guideline Q4B annex 2 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/559409/2007 Legal effective date: 01/12/2008

ICH: Q 4 B Annex 2: To note evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter - Step 3

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/559409/2007