Drug stability testing is to examine the quality changes of drugs under different environmental conditions to determine the storage conditions, shelf life and stability characteristics of the drugs.
Stability testing mainly includes long-term testing, accelerated testing and influencing factor testing. Long-term testing is carried out under the storage conditions specified for marketed drugs. The purpose is to investigate the stability of drugs during transportation, storage and use. It can directly reflect the stability characteristics of drugs and is the basis for determining the shelf life and storage conditions. Accelerated testing is carried out under abnormal conditions. The purpose is to study the stability of drugs by accelerating the chemical or physical change rate of drugs in commercial packaging. It aims to simulate the stability of drugs under short-term abnormal conditions that may be encountered during transportation and storage, and preliminarily predict the long-term stability of samples under specified storage conditions. Testing of influencing factors is carried out under harsh conditions. The purpose is to understand the factors that affect stability, possible degradation pathways and degradation products, and provide a basis for screening preparation processes, selecting packaging materials and containers, and determining storage conditions.
