Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Identifying the Criteria of a Valid Stability Study

Author(s):  Williams LaVonn A, Hastings Mitchell Blaine

Issue:  Jan/Feb 2009 - Compounding for Pediatrics
View All Articles in Issue

Page(s):  32-36

Identifying the Criteria of a Valid Stability Study Page 1
Identifying the Criteria of a Valid Stability Study Page 2
Identifying the Criteria of a Valid Stability Study Page 3
Identifying the Criteria of a Valid Stability Study Page 4
Identifying the Criteria of a Valid Stability Study Page 5

Download in electronic PDF format for $75

Abstract:  The objective of a stability study is to establish specifi cations for the storage of a drug substance or active ingredient, and to ensure that the correct beyond-use date is assigned by demonstrating stability throughout its shelf life. Certain criteria must be met for a study to be considered a valid stability study. The purpose of this article is to clarify the criteria for a valid stability study so compounding pharmacists will understand what to look for when reviewing a stability study to determine an appropriate beyond-use date for compounded preparations.

Related Keywords: LaVonn A. Williams, Mitchell Blaine Hastings, stability studies, stability-indicating assays, reporting standards, quality standards, stability tests, children, dosage forms, beyond-use dating


Printer-Friendly Version

Related Articles from IJPC
(Click for Abstract / Details / Purchase)
Identifying the Criteria of a Valid Stability Study
Williams LaVonn A
, Hastings Mitchell Blaine
Jan/Feb 2009
Pg. 32-36

Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design
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
Jan/Feb 2021
Pg. 73-81

Standards of Practice, Professional Judgment, and Scientific Evidence to Establish and Extend a Beyond-Use Date
Thomson Cassandra Marie
, Savji Taslim
Nov/Dec 2014
Pg. 456-460

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
Pg. 164-170

Physicochemical and Microbiological Stabilities of Hydrocortisone in InOrpha Suspending Agent Studied Under Various Condition
Bourget Philippe
, Amin Alexandre, Vidal Fabrice, Pieyre Manon, Dosso El Ourmar, Beauvais Raphaelle, Loeuillet Richard
Sep/Oct 2014
Pg. 427-431

Assignment of a Beyond-Use Date for Compounded Preparations
Allen Loyd V Jr
Nov/Dec 2000
Pg. 474-475

Beyond-use Date: Establishment and Maintenance
Osteen Richard
Nov/Dec 2012
Pg. 471-474

Quality Control: Lessons Learned from a Trimix Stability Study in a 503A Compounding Pharmacy
Rhoads Rick
Mar/Apr 2018
Pg. 129-134

Basics of Compounding: Clinical Studies
Allen Loyd V Jr
Nov/Dec 2002
Pg. 443-447

Formulation and Accelerated Stability Studies for an Extemporaneous Suspension of Amiodarone Hydrochloride
Alexander Kenneth S
, Thyangarajapuram N
Sep/Oct 2003
Pg. 389-393

Basics of Compounding: Potency and Stability Testing
Allen Loyd V Jr
May/Jun 2013
Pg. 220-224

Chemical Stability of Brompheniramine Maleate in an Oral Liquid Dosage Form
Gupta Vishnu D
, Gupta Vikas S
Jan/Feb 2011
Pg. 78-80

Physical and Chemical Stability of Budesonide Mucoadhesive Oral Suspensions (MucoLox)
Ip Kendice
, Carvalho Maria, Shan Ashley, Banov Daniel
Jul/Aug 2017
Pg. 322-329

Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating
Martin Matt
Jul/Aug 2018
Pg. 303-312

Quality-Control Analytical Methods: Stability Versus Potency Testing: The Madness is in the Method
Kupiec Thomas C
, Skinner Rodney, Lanier Lance
Jan/Feb 2008
Pg. 50-53

Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations
Okeke Claudia C
, Allen Loyd V Jr
May/Jun 2010
Pg. 232-238

Stability Evaluation of Minoxidil in FOAMIL Foam Base with Bracketing Study Design
Lupatini Rodrigo
, Sidhu Raman, Patel Harshad, Bichar Katia
May/Jun 2021
Pg. 236-240

Intravenous Admixture Preparation Considerations, Part 7: Stability Issues
Allen Loyd V Jr
Nov/Dec 2020
Pg. 473-478

PreScription: Stability Studies and United States Pharmacopeia-National Formulary-Grade Chemicals
Allen Loyd V Jr
Sep/Oct 2016
Pg. 356

Extemporaneous Formulations: How to Evaluate HPLC Stability Studies
Chan Debora Schotik
Nov/Dec 1999
Pg. 447-451

Return to Top