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

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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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