null Ph. Eur. tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances – End of trial period postponed

EDQM Strasbourg, France 09/02/2022
Ph. Eur. tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances – End of trial period postponed

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.

The trial period for this policy has been prolonged until the end of February 2023, instead of February 2022 as initially announced; 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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