Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Basics of Compounding: Potency and Stability Testing

Author(s):  Allen Loyd V Jr

Issue:  May/Jun 2013 - Volume 17, Number 3
View All Articles in Issue

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: Loyd V. Allen Jr., PhD, RPh, potency testing, stability testing, stability-indicating methods, high-performance liquid chromatograph, HPLC, ultraviolet-visible spectrophotometry, United States Pharmacopeia, beyond-use date, photo diode array detector


Printer-Friendly Version

Download in electronic PDF format for $35

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Basics of Compounding: Potency and Stability Testing Allen Loyd V Jr May/Jun 2013 220-224 Buy
Quality-Control Analytical Methods: Stability Versus Potency Testing: The Madness is in the Method Kupiec Thomas C, Skinner Rodney, Lanier Lance Jan/Feb 2008 50-53 Buy
Beyond-use Date: Establishment and Maintenance Osteen Richard Nov/Dec 2012 471-474 Buy
Quality-Control Analytical Methods: High-Performance Liquid Chromatography Kupiec Thomas C May/Jun 2004 223-227 Buy
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 Gorman Gregory, Sokom Simara, Coward Lori, Arnold John J Mar/Apr 2017 164-170 Buy
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr Nov/Dec 2003 449-450 Buy
Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations McElhiney Linda F Jul/Aug 2013 307-311 Buy
Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2 Vu Nicole, Lou Jessica R, Kupiec Thomas C Jul/Aug 2014 305-310 Buy
Quality-Control Analytical Methods: Chemical Testing Aspects of USP <797> for Compounded Sterile Preparations Kupiec Thomas C Mar/Apr 2005 136-138 Buy
Standards of Practice, Professional Judgment, and Scientific Evidence to Establish and Extend a Beyond-Use Date Thomson Cassandra Marie, Savji Taslim Nov/Dec 2014 456-460 Buy