Bendamustine Hydrochloride(Monohydrate)Related Substance Analysis And Stability Research

Drug quality standards are a series of drug testing technical methods and indicators specially set to ensure the quality of drugs.They are all basic requirements for achieving the stability of drug efficacy and are also an important basis for strengthening drug quality and safety monitoring.The research of drug quality standards mainly uses various technical means and methods to study and control the quality of drugs,and to detect various indicators of drugs to achieve the main purpose of controlling the quality of drugs.This article investigates and studies the quality of bendamustine hydrochloride(monohydrate)from three aspects: structure confirmation research,related substance analysis,and content determination of the raw material drug bendamustine hydrochloride(monohydrate).Bendamustine hydrochloride(monohydrate)was subjected to stability studies to provide a basis for the formulation of quality standards for bendamustine hydrochloride(monohydrate).1.Research on structural confirmation of bendamustine hydrochloride(monohydrate)Establish a method for structural confirmation of bendamustine hydrochloride(monohydrate)APIs,conduct structural confirmation studies on bendamustine hydrochloride(monohydrate)APIs,and determine the chemical structure of this product as bendamustine hydrochloride(monohydrate)2.Bendamustine hydrochloride(monohydrate)related substances analysis and content determination researchThe analysis and content determination of related substances of bendamustine hydrochloride(monohydrate)raw materials were studied by high performance liquid chromatography.The results show that the established related substance method can comprehensively control the known impurities and unknown impurities of this product,and carry out quality analysis methodological research,the analysis method is reliable and feasible;the content of this product is calculated as anhydrous,and the content is 98.0 %～102.0%;and carry out content determination methodology research,this method is suitable for its content determination.3.Study on the stability of bendamustine hydrochloride(monohydrate)This article carries out influencing factor tests,accelerated tests,and long-term stability studies to investigate the stability of this product under different conditions.In the influencing factor test,the inspection items are basically in compliance with the regulations,but the light has a certain impact on the product,indicating that the product is basically stable,but it should be stored in the dark;in the accelerated test and long-term test,the inspection items are in compliance with the regulations.This product has good stability in a certain period of time.