Europe releases 10th Pharmacopoeia edition with 114 new monographs

Published: 5-Sep-2019

Thoroughly revised general chapters include infrared absorption spectrophotometry and Ultraviolet & visible absorption spectrophotometry

The EDQM/Council of Europe has released the 10th Edition of the European Pharmacopoeia, containing 2,420 monographs and 374 general texts (including general monographs and methods of analysis), as well as around 2,780 descriptions of reagents.

In total, 114 new monographs have been introduced, of these 17 concern active substances of high medical interest covering key therapeutic classes, such as antineoplastics, immunosuppressants, anti-arrhythmics, anti-thrombotics, antiretrovirals or analgesics; and 7 monographs concern finished products containing chemically defined active substances.

Thoroughly revised general chapters include: Infrared absorption spectrophotometry and Ultraviolet and visible Absorption spectrophotometry, with the latter now covering UV-Vis detectors for chromatographic systems and for Process Analytical Technology applications.

Acceptance criteria for elemental impurity levels, as defined in the ICH Q3D guideline, are also reflected in this new edition, which provides standardised approaches for correctly determining elemental impurity levels.

Further work on elemental impurities included the revision of the general monographs on Substances for pharmaceutical use and Pharmaceutical preparations, the general chapters on Elemental Impurities and their Determination, as well as numerous individual monographs.

Biologicals: several new monographs address both existing and innovative treatments, such as Infliximab concentrated solution (2928), the revised general monograph on Products of recombinant DNA technology and a new chapter on the Quantification and characterisation of residual host cell DNA. All offer quality standards for a wide range of biological medicines while allowing for the necessary flexibility.

Dr Susanne Keitel, EDQM's Director explains: "This updated Edition responds to the latest developments in the pharmaceutical sector and defines quality and safety standards for medicines on the basis of scientific expertise. It includes a whole variety of new substances and products, while reflecting the latest scientific and technological advances, as well as recent changes in regulatory processes at European and international level."

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