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European Pharmacopoeia Commission Updates Ph.Eur.
The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.
The European Directorate for the Quality of Medicines & HeathCare (EDQM) announced that the European Pharmacopoeia Commission (Ph.Eur.) announced that the commission held its 152nd session in Strasbourg on June 16–17, 2015. The session resulted in six new texts, 31 revised monographs, and six revised general chapters.
The following were included in the updates:
- A new general monograph on chemical precursors for radiopharmaceutical preparations.
- A revised chapter on the use of the test for bacterial endotoxins, which includes new recommendations on the need to perform risk assessment when using the bacterial endotoxin test as a pyrogenicity test, due to the potential contamination by nonendotoxin pyrogens; and a section on how to set limits for bacterial endotoxins.
- A revision to the general chapter on potentiometric determination of pH.
- A revision to the general chapter on residual solvents to align the latter to the latest version of the ICH Q3C (R5).
- A revised version of the chapter on pyrogens, which recommends replacing this test by the Monocyte-activation test wherever possible and after product-specific validation to avoid the use of live animals.
The new texts become affective July 1, 2016 and will be published in Supplement 8.8 of the Ph.Eur.
Source: EDQM