Achieving Method Modernization with the New Liquid Chromatographic Gradient Allowances
The U.S. Pharmacopeia (USP) portfolio of solutions addresses quality assurance, enhances regulatory predictability, and helps manufacturers distribute quality medicines, dietary supplements, and foods. On December 1, 2022 a harmonized standard for General Chapter <621> Chromatography was released. This standard incorporates the USP with 2.2.46. Chromatographic Separation Techniques European Pharmacopoeia (EuPh) and 2.01 Liquid Chromatography Japanese Pharmacopeia (JP) texts. Harmonization of these regulatory guidance provides increased method flexibility through the employment of modernized of chromatographic tools without the need for full monograph re-validation.
Chromatographic separations are affected by both column hardware and system hardware. These parameters are critical to method performance and limitations can restrict flexibility after monographs are validated. For example, modern HPLC column hardware is commonly offered in 4.6 mm diameter for an array of new stationary phase substituents, while 5 μm HPLC particle sizes have been substituted with ≤3.5 μm particle sizes for comparable separations in less time, and with less solvent. A modern HPLC system, such as the Alliance iS HPLC System (Figure 1), which features high chromatographic separation efficiency, an intuitive touchscreen interface, tool-free column fittings, and extended HPLC operating backpressure limits, provides dependable flexibility when adjusting monograph methods to suit modern column hardware dimensions.
