"solved" ??? [Bioanalytics]

posted by ElMaestro  – Denmark, 2015-07-15 12:35 (3585 d 17:56 ago) – Posting: # 15087
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Dear janmacek,

❝ They really did so by eliminating the reference to European Pharmacopoeia Certified Reference Standards, EPCRS (see EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2) and the problem is thus solved.


No, one problem is solved, but the problem is not.

❝ In the future studies the EPCRS cannot be used anymore.


And this is the real problem. The fact that an ECPRS product is not accompanied by a CoA specifying its purity probably only relates to the fact that it is difficult. It certainly would otherwise be both relevant and highly useful and appreciated by companies traditionally relying on reference standards.

Pass or fail!
ElMaestro

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