22 August 2005 | By Erwin Adams, Ann Van Schepdael and Jos Hoogmartens, Laboratory for Pharmaceutical Chemistry and Drug Analysis, Catholic University of Leuven, Belgium
The European Pharmacopoeia (Ph. Eur.)1 monographs are subject to regular adaptation in order to cope with progressing quality requirements. This contribution outlines the evolution in analytical requirements and techniques in monographs for organic substances. These monographs generally carry the subheadings definition, characters, identification, tests, assay and impurities.