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
