Abstract

Basics of Compounding: Potency and Stability Testing

Author(s): Allen Loyd V Jr

Issue: May/Jun 2013 - Volume 17, Number 3

Page(s): 220-224

Download in electronic PDF format for $75

Abstract

Potency (strength) tests are designed to determine how much of an active drug is in a sample. Stability tests are used to determine an expiration date of a product or a beyond-use date of a preparation. Being able to employ the proper method to determine potency or stability is the key to understanding the difference between potency testing versus stability testing. In order to determine potency, a method may or may not be stability indicating. When determining stability, the method must be stability indicating. When using a stability-indicating method, both potency and stability can be determined. 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-assurance program.

Related Keywords

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page View/Buy	Title/Author (Click for Abstract / Details / Purchase)
May/Jun 2013 Pg. 220-224	Basics of Compounding: Potency and Stability Testing Author(s): Allen Loyd V Jr
Jan/Feb 2008 Pg. 50-53	Quality-Control Analytical Methods: Stability Versus Potency Testing: The Madness is in the Method Author(s): Kupiec Thomas C, Skinner Rodney, Lanier Lance
Nov/Dec 2021 Pg. 491-496	Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations Author(s): Allen Loyd V Jr
Jul/Aug 2013 Pg. 307-311	Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations Author(s): McElhiney Linda F
Nov/Dec 2012 Pg. 471-474	Beyond-use Date: Establishment and Maintenance Author(s): Osteen Richard
Jul/Aug 2014 Pg. 305-310	Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2 Author(s): Vu Nicole, Lou Jessica R, Kupiec Thomas C
Mar/Apr 2005 Pg. 136-138	Quality-Control Analytical Methods: Chemical Testing Aspects of USP <797> for Compounded Sterile Preparations Author(s): Kupiec Thomas C
Jan/Feb 2006 Pg. 36-39	Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations Author(s): Dawson Michael F
Mar/Apr 2021 Pg. 115-124	Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice Author(s): Kelley Brian
Mar/Apr 2017 Pg. 164-170	Development and Application of a High-Performance Liquid Chromatography Stability-Indicating Assay for Beyond-Use Date Determination of Compounded Topical Gels Containing Multiple Active Drugs Author(s): Gorman Gregory, Sokom Simara, Coward Lori, Arnold John J
May/Jun 2017 Pg. 193-203	Microbiologic Testing for 503A Sterile-Compounding Pharmacies Author(s): Mixon William, Roth Abby
Jul/Aug 2020 Pg. 299-303	Quality Control: Rapid Sterility Testing for Compounding Pharmacies Author(s): Taylor Andrew
May/Jun 2014 Pg. 213-221	Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1 Author(s): Vu Nicole, Lou Jessica R, Kupiec Thomas
Jul/Aug 2018 Pg. 303-312	Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Author(s): Martin Matt
Jan/Feb 2021 Pg. 73-81	Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design Author(s): Patel Gopesh, Davis Countaney, Liu Yi, Ip Kendice, Debideen Krystal E, Anderson Stephanie, Byrne Robert, Herr Dylan, Rhoads Melissa Merrell, Caputo Ross, Banov Daniel, Bassani August S
Sep/Oct 2009 Pg. 412-418	Quality-Control Analytical Methods: Designing a Quality-Control Potency Testing Program for a Compounding Pharmacy Author(s): Zolner William J
May/Jun 2004 Pg. 223-227	Quality-Control Analytical Methods: High-Performance Liquid Chromatography Author(s): Kupiec Thomas C
Mar/Apr 2014 Pg. 123-130	Quality Control Analytical Methods: The Essentials of United States Pharmacopeia Chapter <51> Antimicrobial Effectiveness Testing and Its Application in Pharmaceutical Compounding Author(s): Vu Nicole, Nguyen Devin, Kupiec Thomas C
Nov/Dec 2014 Pg. 456-460	Standards of Practice, Professional Judgment, and Scientific Evidence to Establish and Extend a Beyond-Use Date Author(s): Thomson Cassandra Marie, Savji Taslim
Sep/Oct 2015 Pg. 383-386	Using Hospital Laboratory Services to Perform Quality-control Testing on Compounded Preparations Author(s): Donnelly Ronald F