Texts adopted by the Ph. Eur. Commission

Recommendation

18 February 2020
Frankfurt/Main, Germany

Nitrosamine Impurities

The European Pharmacopoeia Commission adopted 28 new monographs and 3 new general chapters during its 153rd Session in Strasbourg from 17-18 November 2015.

The Texts will be published in the 9th Edition of the Ph. Eur. and shall become effective on 1st January 2017.

As it has been previously published in Pharmeuropa 27.2 the commission adopted the deletion of the test for Heavy Metals (2.4.8) from approx. 760 individual monographs on substances for pharmaceutical use.

Among the new general chapters adopted is the general method Qualitative high performance thin-layer chromatography of herbal drugs and herbal drug preparations (2.8.25).

The Commission also adopted 5 revised general chapters and 114 revised monographs, including 42 revised monographs on veterinary vaccines and the general monograph on Vaccines for veterinary use (0062).

The general monograph (0062) and three individual monographs (0447, 1939 & 2674) also include promotion of the move from final product controls to consistency of production. What exactly is meant  by "consistency of production" will be subject of a dedicated press release to be published on the EDQM website soon. There might be a correlation to the recently published Draft of Annex 17 (Draft Annex 17: Real Time Release Testing, Revision 1).

Additionally, drafts for revised chapters Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) in view of the ICH Q3D Guideline on Elemental impurities will be published for public inquiry in Pharmeuropa 28.2.

For further Information please visit the EDQM Website.