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)

See EDQM- https://www.edqm.eu/sites/default/files/press_release_ph_eur_162nd_session_november_2018.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology