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Updated: Jan 13, 2026

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
An available strategy for preparation of the major impurities in tacrolimus by silver ion complexation and
Xiao-Jing Gao1, Ling-Bin Yan1, Zhou-Qin Chen1
1Fujian Provincial Key Laboratory of Screening for Novel Microbial Products, Fujian Institute of Microbiology, Fuzhou 350007, China.
Abstract:
Tacrolimus, a highly potent immunosuppressive agent produced by Streptomyces actinomycetes, is accompanied by structurally analogous impurities during its biosynthesis. In this study, a separation strategy combining silver ion complexation and preparative liquid chromatography technology was developed for isolating the major impurities in tacrolimus. Structural characterization was performed using liquid chromatography-mass spectrometry and nuclear magnetic resonance (NMR) spectroscopy. The results demonstrated that this integrated strategy effectively separates the impurities, which were identified as ascomycin, dihydrotacrolimus, and desmethylascomycin. To the best of our knowledge, this is the first report on the presence of desmethylascomycin, an unknown impurity, in tacrolimus. In conclusion, this study established a reliable and efficient method for separating and identifying tacrolimus impurities, providing a valuable contribution to the field of pharmaceutical analysis and quality control.
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