Study On The Quality Of The Raw Material Of 1-Methylhydantoin And Its Stability

Purpose: This article on raw materials of l-Methylhydantoin for better quality,focus on the relative substance of l-Methylhydantoin and determination method and its limits and stability research on the system.Method:In this thesis, the quality control in-depth study about l-Methylhydantoin is established for chemical identification,checking impurities, the relative substance and substance determination etc.For the first time,HPLC-DAD detector is used to identify and determine the relative substance, with the usage of agela venusil MP C18 column(5um,250mm×4.6mm), the mobile phase was 0.2% phosphate solution, 200nm as detective wavelength. In the identification of the relative substance of 2– (1 - methyl - urea - based) acetic acid structure, use element analysis, EI-MS, 1H-NMR, 1C-NMR, IR and so on analysis of modern spectrum technologies and final set at 2– (1 - methyl - urea - based) acetic acid.Result:The established method has a good specification,linearity and precision within the range of 0.10- 0.60ug (r=0.9997),the limit of detection is 2ng(S/N=3). The analysis percision RSD was 0.12%,The repeatabiliy Precision RSD was 0.67%. It also established acid-base method using non-aqueous . At the same time the quality criteria for the l-Methylhydantoin was developed as well as the stability test and accelerated test of l-Methylhydantoin; the results show that l-Methylhydantoin stabilizes in front of the light, moisture, thermal.Conclusion:This thesis provides a quality standards basis for making l-Methylhydantoin Raw Materials, storage conditions and validity, at the same time, lays a foundation for the research and development of preparation and the design of production technology standards. Not only does it fill the blank of the research field of the quality control of l-Methylhydantoin at home and abroad, but also paves the way for making l-Methylhydantoin a nation-class medicine and its wider application.