News & events

Cindy Pickens, ARL Bio Pharma Laboratory Supervisor Particulate Matter testing is performed on all parenteral solutions to determine the cleanliness and stability of the solution; and, is listed in USP <797> as a necessary component for quality assurance of compounded sterile preparations under the responsibilities of compounding personnel. It is also specifically outlined as a

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