European Pharmacopoeia Commission Updates Ph.Eur.

The European Directorate for the Quality of Medicines & HeathCare (EDQM) announced that the European Pharmacopoeia Commission (Ph.Eur.) announced that the commission held its 152^nd 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