As USP global initiative to modernize existing monographs across all compendia, objectives and criteria for the monograph modernization are discussed. Identification, assay and organic impurities tests in the USP monograph are highlighted with modern analytical techniques for the modernized monograph. Orthogonal identification and organic impurities test with specified impurities are discussed in the presentation. Multi-sourced sample procurements and method development by USP internal laboratories are utilized to fulfill the test method requirements in the monograph, along with a case study for the critical steps of the method developments. It is expected that, with the initiative and the efforts for the revisions, the modernized monographs will be helpful to achieve our mission of providing high-quality public standards as to improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and food. |
