GT145 - Japanese Pharmacopoeia, 18th Edition Analysis of Macrogol 400 - 2.00 Change of Conditions Specified within General Theory of Chromatography

Adjustable range of chromatography conditions has been specified in [2.00 General theory of chromatography] which has been stipulated based on the contents harmonized and agreed upon by Japanese/U.S./European Trilateral Pharmacopoeia at the first supplemental public comment of the Japanese Pharmacopoeia, 18th Edition, which was disclosed in September 2021. Based on this, the acceptable changeable range of conditions is widened, enabling easier requirement study. In this report, an analysis was implemented by changing the column size within the range specified in [2.00 General theory of chromatography] for JP18 Purity Test (2) of Macrogol 400. The change of analytical conditions is for the content to be applied from the first supplemental revision of JP18 and is not for the content announced in the past. Accordingly, this Technical Note is simply just for reference.