European Pharmacopeia: Works programme

The European Pharmacopeia intends to assess the following during 2018:

• 2.6.40. Monocyte-activation test for vaccines containing inherently pyrogenic components
• 5.26. Implementation of pharmacopoeial methods
• 5.27. Cross validation
• N-Boc-O-dimethoxytrityl-O’-nosyl-thymidine precursor for radiopharmaceutical preparations (3091)
• Erlotinib hydrochloride (3094)
• Eschscholzia herb (3088)
• (S)-3-(5-Formyl-4-methoxymethoxy-2-nitrophenyl)-2-(trityl-amino)-propionic acid tert-butyl ester precursor for radiopharmaceutical preparations (3093)
• Fulvestrant injection (3096)
• Helichrysi flos (3089)
• (2S)-O-(2‘-O’-Tosyloxyethyl)-N-trityl-tyrosine tert-butyl ester precursor for radiopharmaceutical preparations (3092)
• Vibriosis vaccine (inactivated) for sea bass (3090)
• Vincamine (1800)

Furthermore, the following text is due to be revised:

2.6.27. Microbiological examination of cell-based preparations: “Clarification of the section 3-1-2 dealing with method suitability.”

Posted by Dr. Tim Sandle