EDQM：暂定各论草案中含量RSD≤1.0 210504

Tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances

含明确化学结构的活性物质的药品各论含量RSD临时政策

News

04 May 2021

Strasbourg, France

When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS.

A trial period for this policy will run until the end of February 2022; any comments received during the Pharmeuropa public enquiry will be assessed and the policy will be amended or confirmed as appropriate.

如果实验结果可接受，药典在线上发布的各论草案中，含活性物质CRS的溶液中峰面积重复性要求RSD将定为≤ 1.0%(n=6)。

该政策试验期将持续至2022年2月。我们将对药典公开征求意见期间所收到的建议进行评估，适当时对该政策进行修改或确认。