Improve Your USP LC Gradient Separation Methods Following The New <621> Guidelines

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Webinar Date/Time: Airing 1: Tuesday, February 28th, 2023 at 9am EST | 6am PST | 2pm GMT | 3pm CET Airing 2: Tuesday, February 28th, 2023 at 2pm EST | 11am PST | 7pm GMT | 8pm CET

Want to speed up your existing USP gradient methods without a revalidation? Join us for how to use the approved guidelines and save solvent at the same time by switching to a superficially porous particle column.

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Event Overview:

The guidelines in USP Chapter <621> were recently updated to allow changes to gradient methods in terms of particle size and column dimensions with verification instead of revalidation. This change enables laboratories to benefit from modern column particle sizes and dimensions, creating both time and solvent savings since existing methods may be using classic particle sizes and dimensions and long run times. This presentation will highlight the benefits of moving from gradient methods that use fully porous particle columns to superficially porous particle columns. A case study will also be discussed showing how small changes in particle size will not impact the overall system suitability of the method.

Key Learning Objectives:

  • Review the guidelines of USP Chapter <621> for changing both isocratic and gradient methods
  • Understand how to convert USP methods to use modern superficially porous particle columns
  • Realize the benefits of moving to gradient methods that use superficially porous particle columns

Who Should Attend:

  • Analysts running USP methods
  • Method developers for generic pharmaceuticals
  • Anyone interested in learning more about getting the most from SPP column technology for improving their fully porous particle methods


Stephanie A. Schuster, Ph.D.
Senior Technical Support Scientist
Advanced Materials Technology, Inc.

Dr. Stephanie A. Schuster earned her Bachelor of Arts degree in Chemistry and Biochemistry in 1998 at La Salle University, where she graduated cum Laude from the Honors Program. She earned her Ph.D. in 2007 under the guidance of Professor Joe P. Foley at Drexel University. Her doctoral dissertation focused on the use of vesicles as pseudostationary phases in capillary electrophoresis. This system was investigated as a potential in vitro model for intestinal permeability.After earning her Ph.D. at Drexel, Dr. Schuster joined Atlantic Diagnostic Laboratories (ADL), a combined clinical and forensic testing laboratory. While at ADL, she authored a procedure manual, and co-authored or contributed to other documentation, in preparation for College of American Pathology (CAP) inspection. She was instrumental in implementing general laboratory improvements (appropriate labeling, daily maintenance logs, etc.) in accordance with CAP guidelines. Dr. Schuster also assisted with method development using an Applied Biosystems 3200 Q TRAP LC/MS/MS System.

Beginning in June of 2009, Dr. Schuster joined Advanced Materials Technology, Inc. (AMT) located in Wilmington, DE as a research scientist working with Dr. Jack Kirkland, providing contributions to the commercial development of products specifically designed for the separation of peptides and proteins. During the summer of 2015, Dr. Schuster began to transition away from research and development activities and more toward applications development and quality assurance. She is currently a Senior Technical Support Scientist at AMT. As such, Dr. Schuster works closely with AMT’s worldwide network of distributors and assists customers with optimizing and trouble-shooting their applications. Her primary interests are separations and novel materials development. Dr. Schuster has several peer-reviewed articles and is currently a member of the Chromatography Forum of the Delaware Valley.

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