European Pharmacopoeia Commission Adopts New and Revised Texts

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced 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)

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.

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.
Posted by Tim Sandle