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.
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European Pharmacopoeia (Ph. Eur.) Commission
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.