Pharmacopoeias contain generally applicable rules on the quality and testing of pharmaceuticals. There are numerous pharmacopoeias worldwide. The official pharmacopoeia for the USA is the United States Pharmacopoeia (USP) and for Europe the European Pharmacopoeia (EP).
The monographs describe the methods to control the purity of drugs. Often drugs and their impurities are analyzed with HPLC. The pharmacopoeias also list the permitted changes to adapt a method. For example, column length and particle size can be changed within certain limits without having to revalidate a method.
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In a short video we give an overview of the allowed adjustments of some parameters according to USP and EP. In addition, we show for eight drugs the successful separation from their impurities with our HPLC columns according to official methods and the optimization of the methods with our NUCLEOSHELL HPLC columns.
