Ph. Eur. 0417: Oxygen (minimum 99.5%)

What the monograph covers

Monograph 0417 is the European Pharmacopoeia standard for Oxygen (Oxygenium). Since issue 12.3 its definition states that it covers oxygen produced by cryogenic distillation, and EDQM gives its specification as a minimum of 99.5% O2. Oxygen made by adsorption plants has its own monographs: Oxygen (93 per cent), 2455, for single-stage plants, and Oxygen (98 per cent), 3098, for two-stage plants. WHO notes that cryogenic liquid oxygen is always produced off-site and delivered to the hospital, and that cylinders are filled at a gas manufacturing plant either by cryogenic distillation or by a PSA plant.

Status

On 22 October 2026 the EDQM Knowledge database lists monograph 0417 as in use. The full text, with its tests and impurity limits, is in the subscription edition of the European Pharmacopoeia; the public EDQM pages show its status and history.

How it compares with other oxygen monographs

What it means for a hospital or designer

• Do not mix up the US and European minimums: USP Oxygen requires at least 99.0%, Ph. Eur. 0417 at least 99.5%.
• According to ISO 7396-1, a pipeline where all sources deliver oxygen has a concentration above 99%; if oxygen 93 sources feed the same pipeline, the concentration can vary between 90% and more than 99%.
• The International Pharmacopoeia allows its oxygen qualities to be mixed for clinical use but does not apply its requirements to any mixture, and the Portuguese ACSS specification ET 03/2006 recommends a separate or dedicated network for oxygen 93. Decide early whether oxygen 93 and 99.5% oxygen will share a network.
• In England, HTM 02-01 treats medical gases as medicines that must comply with the Human Medicines Regulations 2012 and the relevant British Pharmacopoeia monographs.

Related standards

• Ph. Eur. 2455: Oxygen (93 per cent).
• Ph. Eur. 3098: Oxygen (98 per cent).
• International Pharmacopoeia: Medicinal oxygen, 13th edition (2025).

ULTRAOX SC and ST PSA plants from Ultra Controlo state a purity of 94% (±1%) in their datasheets, which falls in the oxygen 93 range of 90.0% to 96.0% rather than under monograph 0417.