Related Experiment Video
Updated: May 8, 2026

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody (mAb) by Neutralizing TNF Using an In Vitro Bioanalytical Method
Published on: September 16, 2017
Stability Versus Potency Testing: The Madness is in the Method
Thomas C Kupiec1, Rodney Skinner, Lance Lanier
1Analytical Research Laboratories, Inc., Oklahoma City, Oklahoma.
Abstract:
Potency tests, known as quantitative tests, are designed to determine how much of the active drug is in the sample. Stability tests are used to determine a beyond-use date for a preparation. Employing the proper method to determine potency or stability is key to understanding the difference between potency testing and stability testing. Methods of determining potency may or may not be stability-indicating, but stability can be determined only by a stability-indicating method. A stability-indicating method can determine both potency and stability. Quality assurance programs are essential to establishing standards for compounded preparations. It is important that compounding pharmacists understand the differences between potency and stability tests and that these tests are made an integral part of the quality asurance program.
More Related Videos
07:02A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
04:50Reproducibility and Harmonization in Research Using Biological Standards: The Example of Platelet Agonist Collagen-Related Peptide
Published on: August 4, 2023
Related Concept Videos
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Drug Product Stability
In Vitro Drug Dissolution: Compendial Testing Models II
In Vitro Drug Dissolution: Compendial Testing Models I
Toxicity Testing in Animals
Dose-Response Relationship: Potency and Efficacy