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Drug components differ in purity, specifications and quality. According to FDA draft guidance, it’s important for compounding pharmacies and outsourcing facilities to verify drug components purchased from suppliers. Pharmacists verify drug components by: The FDA draft guidance for 503B outsourcing facilities states that “in lieu of testing each shipment of each ingredient, a COA can

Kathy Heatherly, MSFS, ARL Technical Sales A bulk substance, also known as an active pharmaceutical ingredient (API), is often the starting point of a compounded preparation.   Prior to use, compounding pharmacies and outsourcing facilities should confirm the quality of an active pharmaceutical ingredient to ensure consistency of the material as received from the supplier and suitability for use

Importance of Forced Degradation in Stability-Indicating Methods Pharmacists often want to assign a beyond-use date (BUD) on a drug product longer than USP guidelines to increase compounding efficiencies and reduce drug waste. For accurate BUD assignment, Stability-indicating methods are recommended as opposed to Potency methods. Stability-indicating methods are specifically designed to separate drug degradants from

Dr. Qiang Liu, Research and Development Laboratory Supervisor A beyond use date (BUD) is the date after which a compounded preparation shall not be used. The BUD is determined from the date the preparation is compounded. This date should be based on drug-specific, scientifically valid studies when possible. Things to consider when assigning BUD include:  

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

Potency Test Failure Case StudiesBerenice 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