Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Plate number requirements for establishing method suitability.

Gregory K Webster1, Angel R Diaz, Donna S Seibert

  • 1Analytical Research & Development, Michigan Pharmaceutical Sciences, Pfizer Global Research and Development, Ann Arbor, MI 48105, USA.

Journal of Chromatographic Science
|April 14, 2005
PubMed
Summary

Setting realistic plate number specifications for chromatographic methods ensures analytical system suitability without overly strict requirements. This approach maintains essential resolution for pharmaceutical quality control testing.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

PCRX-201, a novel IL-1Ra gene therapy treatment approach for low back pain resulting from intervertebral disc degeneration.

Gene therapy·2024
Same author

Development of Centrifugal Partition Chromatography for the Purification of Antibody-Drug Conjugates.

Analytical chemistry·2023
Same author

Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging.

Molecules (Basel, Switzerland)·2021
Same author

Stability Indicating Method for Polysorbate 80 in Protein Formulations.

Journal of chromatographic science·2020
Same author

Analysis of PEG 400 in perfusate samples by aqueous normal phase (ANP) chromatography with evaporative light scattering detection.

Analytical methods : advancing methods and applications·2020
Same author

Biphasic Dissolution as an Exploratory Method During Early Drug Product Development.

Pharmaceutics·2020

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Science
  • Chromatography

Background:

  • Method validation and transfer are routine in pharmaceutical testing.
  • Chromatographic methods rely on parameters like resolution, tailing, and plate number.
  • Overly strict specifications can hinder method transfer to quality control.

Purpose of the Study:

  • To discuss the establishment of realistic plate number specifications for chromatographic methods.
  • To ensure analytical system suitability and equivalent performance to original validation.
  • To maintain minimum resolution for critical analyte pairs.

Main Methods:

  • Review of common chromatographic method validation parameters.
  • Analysis of the relationship between plate number and chromatographic resolution.

Related Experiment Videos

  • Discussion on setting appropriate plate number specifications.

    • Main Results:

    • Plate number specifications often exceed the minimum required for adequate resolution.
    • Realistic plate number settings can be established while maintaining critical resolution.
    • Appropriate specifications facilitate seamless method transfer from research to production.

    Conclusions:

    • Realistic plate number specifications are crucial for efficient pharmaceutical method transfer.
    • Overly stringent requirements can impede quality control processes.
    • Balancing resolution needs with practical specifications optimizes analytical system performance.