Establishment of national reference standard of ascomycin
A Yu-mei
WEI Wen-zhi
ZHANG Min-juan
LI Jin
Abstract：Objective:To establish the first batch of national reference substance of ascomycin,in order to provide guarantee for the quality control of the impurity,ascomycin,in tacrolimus.Methods:The structure of ascomycin was identified by LC-HRMS and NMR.The NMR signal of ascomycin was accurately assigned.The content of ascomycin was determined by mass balance method and further verified by quantitative nuclear magnetic resonance(QNMR)and external standard method to ensure the accuracy of the data.The uniformity and stability of ascomycin were studied by high performance liquid chromatography(HPLC)to ensure the uniformity and stability of ascomycin reference substance.Results:The content of(C43 H69 NO12)(sum of ascomycin and isomer)was 96.0%in this batch of ascomycin standard substance.Conclusion:The first batch of national standard substances of ascomycin(C43 H69 NO12)was successfully developed.
Keywords：tacrolimusascomycinnational reference substancemass balance methodquantitative nuclear magnetic resonancestructure confirmation
Publication Date：2026-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 621-626 )