Wednesday, 9 January 2019

162nd Session of the European Pharmacopoeia Commission




At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts:

Four general chapters: Quantification and characterisation of residual host-cell DNA (2.6.35);
Powder flow properties by shear cell methods (2.9.49); Scanning electron microscopy (2.9.52) and Process analytical technology (5.25).

Three monographs elaborated under the P4 procedure for products still under patent
protection: Dronedarone hydrochloride (3039); Prasugrel hydrochloride (3040) and Tapentadolhydrochloride(3035).

Plus monographs on:
  • Benzydaminehydrochloride(2759)
  • Tetracaine(2909)
  • Topiramate(2616)
  • Vincamine(1800)
  • Serratulacoronata (2754)
  • Cocoabutter(2607)
  • Squalene(2805)
  • Infectious pancreatic necrosis vaccine(inactivated )for Salmonids(3063)
  • Abelmoschicorolla (2827)



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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