News & events
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Microbial Disinfectant Cleaning Challenge Studies
Read MoreJames Zellner, ARL Bio Pharma Technical Sales How do you know your staff is doing a thorough job disinfecting surfaces and equipment at your facility? Do you have proof that your cleaning procedure is effective in removing potential contaminants from surface areas? An important part of a complete quality program is generating data that the
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Particulate Matter Testing
Read MoreCindy 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
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Benefits of Submitting Master Formulation Records
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Stability Versus Potency Testing: The Madness is in the Method
Read MoreAbstract: 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
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Drug Diversion: Revealing the Truth through Science
Read MoreAaron 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
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Potency Test Failure Case Studies
Read MoreBerenice 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