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

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.

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