The stability of an active drug substance or formulation refers to its ability to maintain physical, chemical, biological, and microbiological properties. Through the design test, the quality characteristics of the API or preparation change over time under the influence of various environmental factors are obtained, which provides supporting information for the determination of the prescription, process, packaging, storage conditions and expiration date of the drug.
The stability of a drug is a necessary characteristic to meet its clinical use and circulation, and it is also an important part of drug quality research, which runs through the entire life cycle of a drug.
By analyzing the requirements and implementation points of drug stability research in relevant laws and regulations at home and abroad, this paper provides reference and reference for the development of stability testing.
07/03 at 19:00 p.m, Mr. Gong Gang, deputy director of Mingjie Pharmaceutical, will bring you a theme for[Regulatory requirements and implementation points of drug stability research].live streaming.
The reservation channel has been opened, and there is even more in the live broadcast roomMultiple surprise giftsWaiting for you to pick it up, everyone is welcome to participate
Gong Gang, Deputy Director of Mingjie Pharmaceutical
Graduated from China Pharmaceutical University, with more than 10 years of experience in quality research and project management in the field of pharmaceutical analysis, he joined Mingjie Pharmaceutical in 2018 and is responsible for IND application (40+) of small molecule innovative drugs, DMF filing of APIs, drug stability research, impurity research, chromatographic method development and verification, excipient testing and other businesses.