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    Molnár-Institute insights will lead NJCG webinar on HPLC harmonization under USP <621>

    news-releasesMolnár-Institute for applied chromatography
    June 13th 2024

    Berlin: – The Molnár-Institute for Applied Chromatography will be a leading contributor to an international webinar that traces the evolution of chromatography and the harmonization of various approaches under USP <621>.

    The free-to-register webinar ‘Evolution of Chromatography and Compendial Approaches: Harmonization of USP <621> Chromatography’ is being hosted by the North Jersey Chromatography Group (NJCG) as a two-hour session commencing 0900 hrs EST (1400 hrs. UTC) on Friday June 21, 2024.

    Evolution of HPLC

    Molnár-Institute President Dr. Imre Molnár will launch the session with his ‘Overview of the Chromatography Evolution Over The Past Years’ that traces how liquid chromatography successively replaced gas chromatography from the 1950s onwards with the introduction of different stationary phases, accelerating with the introduction of Reversed Phase Chromatography during the 1970s and Csaba Horváth’s pioneering “Solvophobic Theory” work in identifying the energy balances of different physico-chemical forces in the retention process.

    He compared all possible forces and found, that the strongest, most dominant force was originated from the highly organized structure of the aqueous eluent, which is in a kind of “liquid diamond” structure with high symmetry and high surface tension, by which hydrophobic molecules are retarded on a hydrophobic-C18-RP-stationary phase surface, forced together by the water molecules around.

    During the 1980s and beyond, a myriad of new RP-stationary phases entered the market, along with development of shorter columns, greatly speeding up analysis time. These paved the way for further breakthroughs in realization of the importance of the water structure, the influence of the ionic strength, of the pH and of the ternary eluent composition (AcN vs. MeOH), leading to almost complete replacement of isocratic elution by gradient methods, made even more powerful by the development of computer modelling, including Molnar’s development of the DryLab platform based on the mid-1980s work of Lloyd Snyder in investigating eluent forces.

    Dr. Molnár will also show how modern HPLC can quickly be optimized and controlled by using the Design Space of the eluent and the stationary phase of the method, through 2D and 3D modeling.

    The Multidimensional Design Space

    This aspect will be amplified by leading Molnár-Institute scientist Arnold Zöldhegyi, who will explore the use of multivariate modeling tools to uniquely characterize complex liquid chromatography (LC) separation systems.

    The presentation ‘Exploring Column Selectivities Using Multidimensional Analytical Design Spaces for Identifying Replacement Columns and Conditions’ is based on a case study in which a systematic Design Space (DS) modeling workflow is created to compare 3-dimensional separation models of amlodipine and its related impurities, with a goal of identifying common conditions under which columns can be easily interchanged.

    He will highlight the surprising results discovered from testing five USP L1-group C18-modified ultra-high performance liquid chromatography (UHPLC) columns. These findings underscore the importance of detailed, model-based investigations for understanding column selectivities and optimizing method conditions across various stationary phases.

    Updates on USP <621>

    Finally, Dr. Amanda Guiraldelli, Scientific Affairs Manager of the United States Pharmacopeia (USP) will provide a latest update on the harmonization of the USP general chapter <621>, to align with the European Ph. Eur. and Japanese JP pharmacopeias.

    Since the harmonization first became official in the USP-NF in December 2022, there have been some major changes and Dr. Guiraldelli will discuss their implications including changes in terminology and definition of chromatographic parameters, new system suitability requirements for sensitivity and tailing factor (to become official in 2025) and adjustments of chromatographic conditions now permitted for gradient elution.

    She will also outline best practices for applying the changes allowed in USP <621>.

    About MOLNÁR-INSTITUTE

    Founded in 1981, Molnár-Institute develops DryLab®4, a software for UHPLC modelling for a world-wide market. Its powerful modules gradient editor, peak tracking, automation, robustness and Design Space Comparison allow for the most sophisticated method development as required across modern pharma industries. Analytical scientists use DryLab®4 to understand chromatographic interactions, to reduce analysis time, to increase robustness, and to conform to Analytical Quality by Design (AQbD) principles, according to the recently published ICH Q14 regulatory framework.

    The Molnár-Institute is a registered partner of the US-FDA, CDC and many other regulatory bodies. DryLab®4 pioneered AQbD long before regulatory agencies across the world encouraged such submissions. Widely implemented by thought leaders, the software contributes substantially to the paradigm shift towards a science and risk driven perspective on HPLC Quality Control and Assurance.

    Further information at: http://www.Molnár-institute.com/

    About NJCG

    The North Jersey Chromatography Group (NJCG) is a topical group of the North Jersey Local Section of the American Chemical Society.

    NJC is an active participant of the EAS (Eastern Analytical Symposium) and CPSA (Clinical & Pharmaceutical Solutions through Analysis). It is a non-profit organization with attendees from academia, industry, and suppliers.

    The group’s mission is to provide a forum where separation scientists can learn, network and develop their careers through seminars, socials, and symposia, focused on providing technical, cutting-edge knowledge while supporting the advancement of separation science products.

    Resources

    Click on NJCC Webinar for further information.
    Click on Register for Webinar for registration page.

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