Achieving Method Modernization With The New Liquid Chromatographic Gradient Allowances Provided By USP General Chapter <621> Chromatography

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 hardware limitations can restrict hardware flexibility after monographs are validated. Discover a modern HPLC system that features high chromatographic separation efficiency, provides dependable flexibility when adjusting monograph methods to suit modern column hardware dimensions, and more.

In combination with this HPLC system, the gradient method allowances described in General Chapter <621> Chromatography were employed to achieve both column dimension and system modernization for the USP monograph separation of antiviral drug, abacavir sulfate. After performing several of the gradient system adjustments provided in USP <621> that facilitate the use of modernized hardware, resulting chromatograms were examined for the ability to meet original monograph system suitability requirements.