Study On Quality Control Of Epasterta Process

Epalrestat,a reversible non-competitive inhibitor of aldose reducase,is an effective and safe drug for diabetic neuropathy.This paper provides a comprehensive,in-depth and systematic quality control study on the industrial production process of epalrestat process to ensure the quality of API and preparation.Firstly,we do a research of the initial material,intermediate product and impurity control in the preparation process of API.The quality of starting materials and solvents is the basis of producing API,which is also directly related to the quality and process stability of the final product and provides impurity information of related substances for the quality study.The study and quality control of intermediate products is also an indispensable part,which is of great significance for the preparation process of stable final products,and can also be used as the basis for structural confirmation research.The experimental results show that the quality control methods of the Starting materials,solvents,intermediate products,crude products has achieved the intended purpose.Secondly,we had confirmed the structure of epalrestat.The structure confirmation of API is the decisive factor to ensure the success of pharmacological and toxicological studies and clinical studies in other aspects of pharmacy.The exact structure of the final product of epalrestat was confirmed through the elemental analysis,IR spectrum,UV,NMR and other map analysis,which fully proved the feasibility of the process route.The structure confirmation and the clarification of physical and chemical properties lay a foundation for the follow-up study on the quality control of the finial products.Finally,Formulate a quality standard of epalrestat.According to epalrestat's characteristic,preparation process and stability,the study on the influence of preparation process on drug quality was carried out,as well as the quality standard project and limit determination.Research on the formulation and revision of quality standards have been studied,and the quality consistency of the original developed drug was compared.The results showed that the structure of the final product was clear.The test method is mature,stable,easy to operate and the results are accurate and reliable.The inspection items mentioned in the quality standards are comprehensive,scientific and reasonable,safe and effective.Since the quality of API has an important influence on the quality of preparation,the process control of API production is another important part,so as to ensure the quality of API and preparation,we have an deeply,systematically study of the quality control of API production process.The study runs through the process design,confirmation of synthesis route,determination of key process parameters,pilot production amplification,mass production verification and product stability research.The quality control methods cover the target materials including starting materials,solvents,intermediate products,crude products,finial products,etc.,which control the quality of the entire production process and ensure to produce safe,effective,stable products.Quality control is a process of continuous improvement.It's very necessary to continuously carry out the research with the continuous optimization of production process,continuous improvement of inspection methods and the accumulation of long-term stability inspection data.