Abstract

Quality Control: Lessons Learned from a Trimix Stability Study in a 503A Compounding Pharmacy

Author(s): Rhoads Rick

Issue: Mar/Apr 2018 - Volume 22, Number 2

Page(s): 129-134

Download in electronic PDF format for $75

Abstract

Changes in California regulations regarding beyond-use dates of sterile preparations have prompted many compounders to consider stability studies for their formulas. Traditionally, 503A compounders have relied on published data and professional experience to determine stability. However, due to these new regulations, stability studies are now required for California resident and nonresident licensees to extend the beyond-use date of sterile preparations. Conducting studies for the first time can be costly and difficult for compounding pharmacists. This article shares several lessons learned from the author’s experience performing stability studies on Trimix injection, a sterile preparation for erectile dysfunction. Avoiding easily made errors can save the compounder unnecessary time and expense.

Related Keywords

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page View/Buy	Title/Author (Click for Abstract / Details / Purchase)
Mar/Apr 2018 Pg. 129-134	Quality Control: Lessons Learned from a Trimix Stability Study in a 503A Compounding Pharmacy Author(s): Rhoads Rick
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
May/Jun 2004 Pg. 181-185	Compounding in the Pharmacy Curriculum: Beyond the Basics Author(s): Hinkle Amanda R, Newton Gail D
May/Jun 2004 Pg. 231-235	Long-Term Stability of Trimix: A Three-Drug Injection Used to Treat Erectile Dysfunction. Author(s): Trissel Lawrence A, Zhang Yanping
Nov/Dec 2008 Pg. 524-528	Quality-Control Analytical Methods: Overview of Beyond-Use Dating for Compounded Sterile Preparations Author(s): Trissel Lawrence A
May/Jun 2010 Pg. 232-238	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 Author(s): Okeke Claudia C, Allen Loyd V Jr
Jan/Feb 2021 Pg. 18-23	Reversing Erectile Dysfunction and Urinary Incontinence After Prostatectomy or Radiotherapy: The Stanley Prostate-Cancer Treatment Protocol Author(s): McKettrick Greg, Yoch Doug
May/Jun 2017 Pg. 193-203	Microbiologic Testing for 503A Sterile-Compounding Pharmacies Author(s): Mixon William, Roth Abby
Jul/Aug 2018 Pg. 303-312	Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Author(s): Martin Matt
Jan/Feb 2018 Pg. 7-16	Certification, Accreditation, and Credentialing for 503A Compounding Pharmacies Author(s): Pritchett Jon, McCrory Gary, Kraemer Cheri, Jensen Brenda, Allen Loyd V Jr
Mar/Apr 2004 Pg. 89-94	Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists Author(s): Rahe Hank
Mar/Apr 2019 Pg. 123-130	Basics of Compounding for Sterile, Nonsterile, and Quality Control Compounding: Process Analytical Technology: Appropriate for Sterile and Nonsterile Compounding? Author(s): Allen Loyd V Jr
Mar/Apr 2017 Pg. 95-102	U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies Author(s): Yoch Doug
Jan/Feb 2014 Pg. 6-12	The Role of Compounding in Closing Therapeutic Gaps--Abstracts from FIP 2013 Author(s): Lutz Eugene, Pauletti Giovanni, Carvalho Maria, Davidson Gigi, Ashworth Lisa, Subramaniam Vaiyapuri, Llambí Francesc
Jul/Aug 2013 Pg. 307-311	Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations Author(s): McElhiney Linda F
Jul/Aug 2008 Pg. 344-353	Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Author(s): Allen Loyd V Jr, Okeke Claudia C
Sep/Oct 2019 Pg. 399-402	Sterile Basics: Pharmaceutical Waters Used in Sterile and Nonsterile Compounding Author(s): Allen Loyd V Jr
May/Jun 2019 Pg. 221-228	Basics of Sterile Compounding: Vehicles Used in Sterile Compounding Author(s): Allen Loyd V Jr
Nov/Dec 2012 Pg. 471-474	Beyond-use Date: Establishment and Maintenance Author(s): Osteen Richard
Nov/Dec 2020 Pg. 460-465	Establishing a Structured Pharmacy Training Program in Sterile Compounding Author(s): Dirbas Muhannad, AbuSara Aseel K, Whiyabi Shatha, Harb Rema, Telfah Shorouq