Tentative policy on assay RSDs for monographs on medicinal products…

Tentative policy on assay RSDs for monographs on medicinal products…

SEMrush
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.

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