The stability of pharmaceutical preparations refers to the speed and degree of quality change in a series of processes from preparation to use, and is one of the important indicators for evaluating the quality of pharmaceutical preparations. Stability studies run through the entire process of drug formulation development, production, and use.
The purpose of the stress testing is to understand the factors affecting the stability of the preparation (high temperature, high humidity, light, acid, alkali, oxidation, etc.) and the possible degradation pathways and degradation products, and to provide reference information for the screening of the preparation process, the selection of packaging materials, and the determination of storage conditions. Generally, three aspects of high temperature, high humidity and light are investigated.
(1) High temperature test
Changes in the quality of the preparations were detected at 60°C. If there is a significant change, perform the test again at 40°C.
(2) High humidity test
The preparation is placed in a constant humidity closed container, and the test is carried out under the conditions of a temperature of 25°C and a relative humidity of 90%±5%. If the quality of the preparation has changed significantly, reduce the corresponding test conditions.
(3) Light stability test
The formulation should be fully exposed for photostability testing. The test was continued until the formulation and its packaging were sufficiently resistant to light.
