European Pharmacopoeia Gets Updated

Apr 06, 2018
By BioPharm International Editors

The European Pharmacopoeia Commission announced on April 5, 2018 that it had adopted 19 new monographs and three new chapters to the European Pharmacopoeia (Ph. Eur.). Additionally, during the 160th session of the commission, 51 monographs and 15 chapters were revised. The new and revised texts will be effective April 1, 2019 and will be published in Supplement 9.7 of the Ph. Eur.

The following are included in the Ph. Eur. updates:

  • Six monographs were elaborated under the P4 procedure, Atazanavir sulfate (2898), Everolimus (2918), Fingolimod hydrochloride (2988), Deferiprone oral solution (2987), Lacosamide infusion (2991), and Lacosamide oral solution (2990). This procedure applies to substances still under patent protection.
  • A new monograph on Live biotherapeutic products for human use (3053), and two general chapters (2.6.36 and 2.6.38) on the methods to control microbial contamination of these products.
  • A revised General chapter on infrared absorption spectrophotometry (2.2.24).
  • A revised version of the general monograph on products of recombinant DNA technology (0784).

Also decided by the commission at the session was reactivation of its Working Party on Gene Therapy products in view of recent developments in the field; reengagement of work on a general chapter on a test for bacterial endotoxins using recombinant Factor C, avoiding the use of a reagent coming from endangered species (horseshoe crab); and addition of 18 new texts to its work program, including four new general chapters [on congealing point determination (2.2.68), multivariate statistical process control (5.28), test for bacterial endotoxins using recombinant factor C (2.6.32) and Recommendations on testing of particulate contamination—visible particles (5.17.2)].

Source: EDQM

 

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