Established specifically for their intended use, pharmacopoeial reference standards are thoroughly characterised and their uses may go beyond those described in compendia, although a clear-cut distinction between quantitative use and qualitative use is essential. For example, compendial assay standards for APIs may be used for assay of finished products as long as specific criteria are fulfilled, as stated in chapter 5.12 of the European Pharmacopoeia (Ph. Eur.).
This clarification came during the “13th International Symposium on Pharmaceutical Reference Standards (IRSS)” organised in Strasbourg on 13-14 March by the EDQM and the United States Pharmacopeia (USP), which included dedicated sessions focusing on pharmacopoeial reference standards and their use and establishment, covering reference standards for biologicals and small molecules.
- More information in the press release: Joint EDQM-USP symposium illustrates use of pharmacopoeial reference standards.
- Proceedings of the 13th International Symposium on Pharmaceutical Reference Standards.