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 Concept Videos

You might also read

Related Articles

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

Sort by
Same author

Orosomucoid proteins limit endoplasmic reticulum stress in plants.

The New phytologist·2023
Same author

Assessment of the relationships between invasive endocervical adenocarcinoma and human papillomavirus infection and distribution characteristics in China: According to the new WHO classification criteria in 2020.

Cancer epidemiology·2023
Same author

Next-generation sequencing of cerebrospinal fluid for the diagnosis and monitoring of neurocysticercosis.

Acta neurologica Belgica·2023
Same author

CIRC_0002131 CONTRIBUTES TO LPS-INDUCED APOPTOSIS, INFLAMMATION, AND OXIDATIVE INJURY IN HK-2 CELLS VIA INHIBITING THE BINDING BETWEEN MIR-942-5P AND OXSR1.

Shock (Augusta, Ga.)·2023
Same author

An unusual cause of recurrent abdominal pain in a middle-aged man.

Revista espanola de enfermedades digestivas·2023
Same author

Evaluation of the Roche MagNA Pure 96 nucleic acid extraction platform for the SPF10 line probe assay system.

Journal of applied microbiology·2023

Related Experiment Video

Updated: Dec 24, 2025

Application of I TASSER, trRosetta, UCSF Chimera, HADDOCK server, and HEX loria for De Novo and In Silico Design of Proteins
05:08

Application of I TASSER, trRosetta, UCSF Chimera, HADDOCK server, and HEX loria for De Novo and In Silico Design of Proteins

Published on: July 8, 2025

810

Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins.

Wen-Li Chung1, Jian Yin2, Steven Messick2

  • 1Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080. chungw3@gene.com.

PDA Journal of Pharmaceutical Science and Technology
|April 17, 2020
PubMed
Summary
This summary is machine-generated.

Compendial methods require suitability verification, not full validation, under Good Manufacturing Practice regulations. This ensures analytical method reliability for product testing, especially for protein products.

Keywords:
21 CFR 211.194(a)(2)ANVISAAccuracyColor and Clarity/OpalescenceCompendial method suitability verificationOsmolalityPartial validationPharmacopoeiaPrecisionSpecificitySub-Vis ParticlesVisible particulatespH

More Related Videos

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification
09:04

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification

Published on: August 17, 2015

17.4K
Cell-Type Specific Protein Purification and Identification from Complex Tissues Using a Mutant Methionine tRNA Synthetase Mouse Line
07:39

Cell-Type Specific Protein Purification and Identification from Complex Tissues Using a Mutant Methionine tRNA Synthetase Mouse Line

Published on: April 13, 2022

3.3K

Related Experiment Videos

Last Updated: Dec 24, 2025

Application of I TASSER, trRosetta, UCSF Chimera, HADDOCK server, and HEX loria for De Novo and In Silico Design of Proteins
05:08

Application of I TASSER, trRosetta, UCSF Chimera, HADDOCK server, and HEX loria for De Novo and In Silico Design of Proteins

Published on: July 8, 2025

810
Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification
09:04

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification

Published on: August 17, 2015

17.4K
Cell-Type Specific Protein Purification and Identification from Complex Tissues Using a Mutant Methionine tRNA Synthetase Mouse Line
07:39

Cell-Type Specific Protein Purification and Identification from Complex Tissues Using a Mutant Methionine tRNA Synthetase Mouse Line

Published on: April 13, 2022

3.3K

Area of Science:

  • Pharmaceutical Analysis
  • Analytical Chemistry
  • Quality Control

Background:

  • Compendial testing methods are subject to suitability verification under actual use conditions per US FDA's 21 CFR 211.194(a)(2).
  • Regulatory bodies like ANVISA mandate partial validation or suitability studies for compendial analytical methods.
  • Suitability verification differentiates between visual and instrumental methods, each with specific assessment criteria.

Purpose of the Study:

  • To present approaches for suitability verification of compendial analytical methods.
  • To provide the scientific rationale supporting compendial methods for specific tests.
  • To discuss current challenges and recommendations for protein product analysis.

Main Methods:

  • Categorization of suitability verification into visual and instrumental methods.
  • Assessment of visual methods involves checking color and opalescence against Pharmacopeia standards.
  • Instrumental methods rely on calibration and method control for accuracy, with potential waiver of specificity.

Main Results:

  • Suitability verification for visual methods includes evaluating sample color and clarity/opalescence.
  • Accuracy and precision for visual methods can be assessed through analyst-to-analyst comparisons.
  • Accuracy for instrumental methods is ensured via instrument calibration and method control.

Conclusions:

  • Suitability verification is crucial for ensuring the reliability of compendial methods in pharmaceutical quality control.
  • Specific approaches are outlined for tests including particulates, pH, osmolality, color, and clarity.
  • Addressing challenges in protein product analysis requires tailored recommendations for method suitability.