High Speed LC Analysis of Pharmaceutical Impurities in Compliance with European Pharmacopoeia

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According to "Adjustment of chromatographic condition" described in the 8th edition of the European Pharmacopoeia (EP), parameters in TLC, LC, GC and SFC may be adjusted without revalidation provided that the system suitability requirements are satisfied. For example, reduction in column particle size by 50% is within the permitted range for isocratic elution.

This article introduces an example wherein high speed analysis of pharmaceuticals and related substances was newly developed in compliance with the EP, using the Nexera-i MT integrated high performance liquid chromatograph. Since the Nexera-i MT integrates both HPLC and UHPLC flow lines, it allows method modification to be conducted in a single system, and the new method may be adopted without transferring it to a new system, thus minimizing the work required improving productivity.

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