Extension of the Scope of Pharmacopoeia Reference Standards Planned

GMP News No. 461

GMP News
10 September 2004
 

Extension of the Scope of
Pharmacopoeia Reference Standards Planned

 
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.
   

You will learn all you need to know about reference standards at our international conference "Reference Standards" to be held in Barcelona from 4-5 November 2004. Please click here for the invitation programme.

 
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
  

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK