European Pharmacopoeia adopts Oxygen 98 % Monograph
published on 17/07/2023
Oxygen (98 per cent) (3098) Monograph was officially adopted by the European Pharmacopoeia Commission at its 176th session on June 20 and 21, 2023.
This new monograph will enable healthcare facilities to control the quality of oxygen produced on site with a nominal content of 98.0% (ranging from 96 to 100%) using a “double-stage” adsorption process.
NOVAIR is delighted to share this news, as the only European manufacturer to offer a DS-PSA oxygen generator capable of producing very high purity oxygen on site. The Premium Plus SX oxygen generator can produce medical oxygen with a purity of up to 99.5% with exceptional stability (+/- 0.2%). Premium Plus SX is certified as a Class IIB CE Medical Device.
The monograph on 98% oxygen is the result of a long series of expert meetings at the European Pharmacopoeia and many years of studies and discussions.
Following the publication in 2010 of the monograph on oxygen (93 percent) produced by a single-stage adsorption process, this new monograph recognizes the most advanced on-site oxygen supply sources: a step forward for better access to medical oxygen.
We would like to thank the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe for enabling this major addition to the European Pharmacopoeia.