European Pharmacopoeia Commission Adopts New and Revised Texts

The European Directorate for the Quality of Medicines and Healthcare (EDQM) announced on Mar. 25, 2015 that the European Pharmacopoeia Commission had adopted 20 new monographs and four new chapters and 72 revised texts for inclusion in the European Pharmacopoeia. The additions and revisions will be effective on Apr. 1, 2016 and be published in Supplement 8.7.

Monographs to be added include:

• Five new monographs on active substances [Entecavir monohydrate (2815), Gadobutrol monohydrate (2735), Gefitinib (2866), Pregabalin (2777), Sitagliptin phosphate monohydrate (2778)] that are still under patent protection and were elaborated in close collaboration with their respective innovator companies (P4 procedure).

• A new monograph on Sitagliptin tablets (2927) that was also elaborated under the P4 procedure. This is the first finished product monograph containing a chemically defined active substance adopted.

Chapters that have been added or revised include:

• Chapter 5.21, Chemometric methods applied to analytical data, provides an introduction to the use of chemometric techniques for processing analytical data sets. The non-binding chapter provides recommendations and requirements for good chemometric practice.

• Chapter 5.19, Extemporaneous preparation of radiopharmaceuticals describes non-binding standardized procedures for preparing radiopharmaceuticals of appropriate quality.

• Chapter 2.5.41 on Methyl, ethyl and isopropyl benzenesulfonate in active substances.

More information on the revised monographs will be published on the EDQM website. 

Source: EDQM