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GMP News No. 461
10 September 2004
Extensionof the Scope of
In this year's July issue of PHARMEUROPA, the journal of the EuropeanPharmacopoeia (EDQM), a draft text on pharmaceutical reference standardswas published.
The most interesting point in this draftis the fact that the scope of the Pharmacopoeia reference standards isplanned to be extended. According to this draft monograph, in the futurethe reference standards in the Pharmacopoeia may in certain circumstancesalso be used for analytical tests that are not described directly in apharmacopoeial monograph for an active ingredient or excipient.
The draft says that pharmaceutical reference standards with an assignedcontent can be employed not only for the assay of substances forpharmaceutical use, but also for the determination of these substances inpharmaceutical products. Up to now, this has not been allowed. However, itgoes without saying that any prior treatment of the sample (e.g.extraction), necessary before the measurement is carried out, has to bevalidated.
From now on, this shall also be possible for Pharmacopoeia referencestandards employed in the test for related substances.
On the whole, this document on the use, establishment and presentationof pharmaceutical reference standards in general and of EuropeanPharmacopoeia reference standards in particular is very detailed andworthwhile reading.