The stability of a drug specifically refers to its ability to maintain the same physical and chemical properties and biological properties. If the stability of the drug is poor, and the quality changes due to component degradation, not only may the efficacy of the drug be reduced, but the generated impurities may also have obvious toxic and side effects, which will affect the safety and effectiveness of the use of the drug.
Therefore, the purpose of the drug stability test is to investigate the law of drug changes over time under the influence of factors such as temperature, humidity, light, etc., to provide scientific basis for the production, packaging, storage, and transportation conditions of the drug, and to establish the validity period of the drug through the test. To ensure the safety and effectiveness of medication.
Stability test research is the basic content of drug quality control research and is closely related to the establishment of drug standards. Stability test research has phased characteristics and runs through the entire process of drug research and development.
Stability test condition introduction:
(1) Accelerated test: 40℃±2℃ / 75%RH±5%RH
(2) Intermediate conditions: 30℃±2℃ / 65%RH±5%RH
(3) Long-term test: 25℃±2℃ / 60%RH±5%RH or 30℃±2℃ / 65%RH±5%RH
