Extension of the Scope of Pharmacopoeia Reference Standards Planned

Extension of the Scope of
Pharmacopoeia Reference Standards Planned

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.