Evaluation, synthesis and characterization of tacrolimus impurities

被引：0
|
作者：
Patrizia Ferraboschi
Diego Colombo
Maria De Mieri
Paride Grisenti
机构：
[1] Biochimica e Biotecnologie per la Medicina,Dipartimento di Chimica
[2] Università degli Studi di Milano,undefined
[3] EUTICALS SpA,undefined
来源：
The Journal of Antibiotics | 2012年 / 65卷
关键词：
ascomycin; 23,24-anhydro tacrolimus; 39,40-dihydro tacrolimus; immunosuppressant; macrolactam;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Tacrolimus is an immunosuppressant macrolactam of fermentative origin. By means of HPLC, LC-MS and NMR analyses, coupled with the reference standard synthesis, the main impurities of tacrolimus bulk drug samples were identified and their chemical-physical properties reported. Known ascomycin and tautomers I and II were detected. The correct relative retention time HPLC value of 39,40-dihydro tacrolimus was established. The not described 23,24-anhydro derivative was detected and completely characterized. A full characterization of ascomycin and 39,40-dihydro tacrolimus was also reported.
引用
收藏
页码：349 / 354
页数：5
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