The European Pharmacopoeia (Ph. Eur.) Commission's new European monograph for Cannabis flower will enter into force in July 2024.
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European Pharmacopoeia (Ph. Eur.) Commission
The rabbit pyrogen test replacement texts in Pharmeuropa 35.1 by the European Pharmacopoeia have been published for public comment.
Adoption of revised general monographs 2034 and 2619 comes after inclusion of a new paragraph approaching N-nitrosamine impurities.
The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
The revised Raman Spectroscopy chapter (2.2.48) will be released in October, with updates focusing on enhancing the reliability of the results.
The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
The recombinant Factor C (rFC) assay has been developed to help alleviate the pressures of a growing demand for the Limulus amoebocyte lysate (LAL) assay. Here, Sven Deutschmann and Johannes Reich discuss the advantages of rFC and its recent recognition by the European Pharmacopoeia as an alternative endotoxin test.