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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

Aaron K. Thompson, Forensic & Technology Leader    Drug diversion is the illegal practice of transferring regulated pharmaceutical agents from legal sources for illicit use.  Instances of drug diversion within the workplace pose a significant risk of civil liability to the employer.  Not only can harm befall the drug-diverter, but contaminated drug products also pose

Berenice Dethier, Research Chemist II A potency test measures the amount of API in a formulation to ensure the product is within its specifications. Criteria for acceptance are set by the client and/or follow the industry benchmarks (generally set by USP). Several factors can contribute to a failing potency result.  Investigating the root cause of the failing

ARL now offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, cassettes, and vials. Three types of leaks that can be detected during CCIT include:   Historically, CCIT has been performed using probabilistic tests such as dye ingress or microbial immersion. Recently, USP issued new guidance requiring deterministic tests to achieve more

Vince Bobin, Laboratory Director Some of the same challenges in creating a formulation are also related to getting accurate and representative results from your Analytical Testing.  This article outlines how to avoid some common issues to help ensure the quality of compounded products. Topics include: Salt vs. Free Base Many pharmaceutical drugs are manufactured as

Andrew Taylor, Microbiology Supervisor Microbial identification is an important component of a quality assurance program; specifically as it relates to environmental monitoring (EM), raw material and final product bioburden assessment, and out-of-specification (OOS) investigations. Environmental Monitoring USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments states “a successful environmental control program includes an appropriate level of