Back Three revised texts related to pharmaceutical waters published in Pharmeuropa 36.3

EDQM Strasbourg, France 05/07/2024
  • Diminuer la taille du texte
  • Augmenter la taille du texte
  • Imprimer la page
  • Imprimer en PDF
Three revised texts related to pharmaceutical waters published in Pharmeuropa 36.3

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the following revised texts, published in this quarter’s issue of Pharmeuropa (36.3) for comment:

  • Water for injections (0169)
  • Purified water (0008)
  • Total organic carbon in water for pharmaceutical use (2.2.44)

The main focus of the revision is the replacement of the test for oxidisable substances (OS) by the test for total organic carbon (TOC) in the section on “Sterilised water for injections” (SWFI) in the monograph on Water for injections (0169).

The TOC test is a state-of-the-art quantitative method that is more sensitive and non-selective than the OS test for the control of organic impurities present in pharmaceutical waters. If adopted, the revision constitutes a major step towards a global quality standard for SWFI, the most widely used excipient in the pharmaceutical industry, with obvious benefits for manufacturers worldwide.

Furthermore, in the proposed revision of general chapter 2.2.44, the reagents sucrose R and 1,4-benzoquinone R have been replaced by chemical reference substances (CRSs) to streamline the application of the TOC test.

The Ph. Eur. would like to encourage all stakeholders to provide their comments on these important texts via the appropriate channel. The commenting period runs until 30 September 2024.

More information on how to comment can be found here: “Comment on drafts (Pharmeuropa)”.