In this year's July issue of PHARMEUROPA, the journal of the European
Pharmacopoeia (EDQM), a draft text on pharmaceutical reference standards
was published.
The most interesting point in this draft
is the fact that the scope of the Pharmacopoeia reference standards is
planned to be extended. According to this draft monograph, in the future
the reference standards in the Pharmacopoeia may in certain circumstances
also be used for analytical tests that are not described directly in a
pharmacopoeial monograph for an active ingredient or excipient.
The draft says that pharmaceutical reference standards with an assigned
content can be employed not only for the assay of substances for
pharmaceutical use, but also for the determination of these substances in
pharmaceutical products. Up to now, this has not been allowed. However, it
goes without saying that any prior treatment of the sample (e.g.
extraction), necessary before the measurement is carried out, has to be
validated.
From now on, this shall also be possible for Pharmacopoeia reference
standards employed in the test for related substances.
On the whole, this document on the use, establishment and presentation
of pharmaceutical reference standards in general and of European
Pharmacopoeia reference standards in particular is very detailed and
worthwhile reading.
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