High-Speed Analysis of Pramipexole following the Draft Guidance of International Harmonization of Pharmacopoeiasr

In JP/USP/EP, moves toward unification of the allowable range of change in prescribed test methods (international harmonization) are underway. As one particularly significant change, revalidation will no longer be required in gradient analysis under uniform high-speed conditions. In July 2017, public comments were solicited and an outline of an international harmonization draft was published.
This article introduces an example of method transfer/migration anticipating the content of the international harmonization guidelines, demonstrating that Shimadzu has substantially completed preparations supporting method transfer/migration by using the dedicated Method Transfer tool for Nexera-i MT.

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Liquid Chromatography
International harmonization, pramipexole, method transfer/migration, high speed, UHPLC, USP, JP, Pharmaceutical, Life Science, Manufacturing, QA/QC, Nexera-i MT
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