• MAY 23RD AAPS EXCIPIENT Community Monthly Scientific Discussion: Measuring nitrite in Pharmaceutica

    Dear all,

        I’m glad to announce that we have invited an expert, Koudi Zhu from IFF to discuss Analytical method advances in measuring nitrite in pharmaceutical excipients in the upcoming scientific discussion for May. Please check Koudi’s bio and presentation abstract below. Look forward to seeing you all next week!

       Time of seminar: May 23rd, 12-1pm US EDT

        Meeting link: see end of this post

      Best regards,

      Jiaying Liu, on behalf of AAPS Excipient Community LT team.

    Koudi Zhu is an Analytical Scientist in IFF Pharma Solutions. Her expertise is in small molecule quantitation with separation techniques such as GC/MS, LC/MS, and IC/MS. Koudi joined IFF in 2021 and in this role, she supports the Pharma Solutions business globally with her analytical leadership, including the development of methods to measure nitrites within the Pharma Solutions excipient portfolio. Prior to her role in IFF, Koudi was an analytical specialist in Dupont 2018-2021 and in Dow Chemical Company 2010-2018, where she supported new product development projects in R&D and process improvement projects in Manufacturing. Koudi obtained her bachelor’s degree in pharmaceutical engineering from China Pharmaceutical University, master’s degree in organic synthesis from Brigham Young University and she is currently pursuing her PhD degree under the supervision of Prof. Gert Desmet from Vrije University Brussel, focusing on the development of multi-dimensional chromatography.

    For the presentation:


    Analytical method advances in measuring nitrite in pharmaceutical excipients


    Regulatory authorities, like the U.S. Food and Drug Administration (FDA), have set maximum daily intake levels for N-nitrosamines in finished drug products. In an acidic environment, nitrite is a potential precursor for the formation of N-nitrosamines when secondary or tertiary amines are also present in the active pharmaceutical ingredient (API) synthesis or formulated drug product. An accurate and sensitive determination of nitrite will be useful when a drug product manufacturer chooses to investigate the reaction kinetics between nitrite and amines or to select appropriate excipients for its drug formulation. Pharmaceutical excipient manufacturers may also benefit from an accurate nitrite measurement to investigate the nitrite content in their excipients. In this talk, we will give an overview on a variety of nitrite testing methods for analysis in excipients. We will discuss in detail an ion chromatography mass spectrometry (IC-MS) method for trace nitrite determination in microcrystalline cellulose (MCC). MS operated under selected ion monitoring mode was used to solve the commonly encountered interference issue with conductivity detection. Nitrite isotope internal standard was employed to address the ion suppression with MS detection. The optimized method was successfully validated with excellent linearity, precision, and recovery. Technical tips and tricks for operating IC-MS system will also be provided. Furthermore, we will share the learnings on developing a more advanced technology - two-dimensional ion chromatography with mass spectrometry detection (2D-ICMS), for nitrite quantitation at parts per trillion level in hydroxypropyl methylcellulose (HPMC) solution.

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