Stability testing is a fundamental part of the drug development process— upholding the quality of active pharmaceutical ingredients (APIs) and drug products while also providing an accurate shelf life. Through stability testing, pharmaceutical companies are able to determine the most suitable packaging and/or container closure system for the storage and distribution of drug products.
“Stability storage and testing plays a big part in the drug development process from research and development up to commercialization and beyond,” said Alcami Senior Manager of Stability Services, Scott Jedrey. “Testing throughout each phase, whether it is physical or chemical, allows data to be gathered, trended, and reviewed. Based on the data, decisions are made on whether to move forward to the next phase, which includes more testing and more patients in several clinical trials. The product must possess the purity, potency, and safety throughout each phase of the drug development process in order to obtain that very important agency approval.”