USP conducts early stage evaluations of new and emerging technologies and trends to identify areas and potential needs for compendial standards. These evaluations also include assessment of analytical technologies that may advance reference standards characterization and enhance compendial testing performance. The evaluation process aids in the determination of potential standards that can then be developed through the USP standard-setting processes. We achieve this by leveraging existing USP resources, and augmenting our capacity through collaboration with external organizations and external expertise and capabilities.
We are currently working on the following projects. Additional topics including digital health, gene/cell therapy, and 3D printing are being explored to better understand their implications and USP’s role in providing guidance and standards.
Quantitative Nuclear Magnetic Resonance (qNMR)
qNMR has the potential to not only improve efficiency of reference standard characterization and streamline compendial testing but also provide higher order evaluation of the materials. Currently, USP is working with external experts to conduct pilot studies and establish a roadmap for USP internal implementation of the qNMR technology.
Research Fellow - Yang Liu
Yang Liu received the Ph.D. degree (Pharmacognosy) from University of Illinois at Chicago, College of Pharmacy, where he worked with Professor Guido Pauli, and studied quantitative NMR (qNMR), countercurrent chromatography, and eutectic phenomenon in natural products.
Yang Liu is experienced in qNMR applications, including identification and quantification of natural products, synthetic APIs, and natural/synthetic polymers. As USP Global Fellow in 2017, he has worked on a project about reference standard determinations using qNMR and development of digital NMR reference standards in Prof. Pauli’s lab. In 2018, he has transited the project to USP Rockville campus, and been honored as USP qNMR Fellow.
USP is exploring DNA Identification methodologies as an orthogonal method for species identification for botanical dietary supplements. This includes evaluating potential reference standards and materials in accord with USP’s goal of disseminating transparent public standards to meet regulatory requirements. USP incorporated DNA-based methods in General Chapter <563> Identification of Articles of Botanical Origin, and published a Stimuli article illustrating the methods, and their strength and limitations.
Research Fellow - Ning Zhang
Dr. Ning Zhang is a scientist working on DNA testing method. He got his Ph.D degree in 2009 in the Chinese Academy of Sciences, Beijing. Until now, he has published 20 peer-reviewed papers and was cited by 609 times as of June 2018. His research areas started from plant evolutionary biology to utilizing DNA testing methods to identify botanical raw materials.