Study on stability test of drugs

Stability testing of drugs in order to ensure that the new ingredients and drugs meet the stringent safety standards, pharmaceutical companies will conduct a large number of light stability tests The stability of drugs refers to that APIs and preparations keep their physical, chemical, biological and microbiological properties Through the study of the stability of APIs and preparations under different conditions (such as temperature, humidity, light, etc.), we can master the law of drug quality changing with time, so as to determine the production, packaging, storage conditions and validity period of drugs To provide basis to ensure the safety and clinical efficacy of clinical medication Stability research is one of the main contents of drug quality control research, which is closely related to drug quality research and the establishment of quality standards Stability research has the characteristics of stages, which runs through the whole process of drug research and development Generally, it starts from the pre clinical research of drugs Stability research should be continued during the clinical research period and after marketing A large number of tests must be carried out before new ingredients and drugs are put on the market Because drug research must comply with strict safety standards According to ICH guidelines (International Conference for coordination of technical requirements for registration of human drugs), stability testing of drugs is an important process for product approval or registration If stability research is not passed, the product cannot be approved The purpose of the study was to demonstrate the shelf life of the drug under specific storage conditions The light stability test conducted within the GMP control range (good manufacturing practice) is used to detect the light stability of new ingredients and drugs, or to be able to show that the ingredients and drugs will not change excessively under light In order to carry out the test effectively, it is important for Zui to keep the light and temperature conditions as stable as possible "Constant temperature must be maintained during the test, and the light dose must reach the rating specified by ICH," said Jens Thielmann, Ph.D., who is responsible for binder's growth and preservation research In order to carry out a series of different tests, many companies and research institutes use binder KBF LQC series constant temperature and humidity boxes The device is characterized by high temperature and a unique lighting scheme for Du, "Thielmann said Binder's light quantum control (LQC) special Li technology can independently control the light dose of UV-A and visible light with the help of 3D spherical sensor which can be placed flexibly, so as to realize the photometric measurement Through the light box which can be placed flexibly, the constant temperature and humidity box can realize uniform light distribution on the whole effective area If the required light intensity is reached, the device will shut down automatically At this time, a temperature from 0 ° C to 70 ° C can be achieved without humidity In the climate operation mode (with humidity), the temperature of 10 ° C to 70 ° C can be reached, and the relative humidity range can be adjusted between 10% and 80%.