Ultra Controlo Medical gas library

Standards

USP (United States Pharmacopeia)

The United States Pharmacopeia (USP) is an independent, nonprofit scientific organisation that develops public quality standards; the official standards in its USP-NF are enforceable by the US Food and Drug Administration (FDA) for medicines made and marketed in the United States.

The USP-NF combines the United States Pharmacopeia and the National Formulary and includes public quality standards for medicines and related ingredients. USP says it has helped shape and advance medicine quality for more than 200 years and that its standards and solutions are used in more than 150 countries.

USP monographs for oxygen include:

  • Oxygen: not less than 99.0% of oxygen.
  • Oxygen 93 Percent: oxygen produced from air by the molecular sieve process, with 90.0% to 96.0% oxygen by volume, the remainder mostly argon and nitrogen.

For the European Pharmacopoeia, an April 2020 EDQM news item described monograph 0417 Oxygen as having an O2 content specification of minimum 99.5%. See Ph. Eur. and USP oxygen 93 compared.

Sources

Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.

Reviewed: · Ultra Controlo engineering · Markdown version

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