Study on Refining Process and Impurities of Tofacitinib Citrate

被引：0

作者：

Xie, Fujia ^{[1
,2
]}

Fang, Zhijie ^{[1
]}

Zhou, Zhihui ^{[2
]}

Feng, Lingling ^{[2
]}

Lu, Jun ^{[2
]}

机构：

[1] Nanjing University of Science and Technology, Nanjing,210094, China

[2] Jiangsu Chiatai Qingjiang Pharmaceutical Co., Ltd., Huaian,223001, China

来源：

Chinese Journal of Pharmaceuticals | 2023年 / 54卷 / 08期

关键词：

Refining;

D O I：

10.16522/j.cnki.cjph.2023.08.005

中图分类号：

学科分类号：

摘要：

In this study, an improved refining process of tofacitinib citrate was reported, and the critical related substances were analyzed and controlled. Tofacitinib was purified in the acetonitrile-water mixed solvent, and the purity of the product was greater than 99.0％. Tofacitinib citrate was recrystallized in water, and the product purity was greater than 99.9％, with maximum single impurity less than 0.05％. The critical related substances of K, U, V and R（detected in the crude product and reference preparation） were synthesized, and their structures were confirmed by 1H NMR, 13C NMR and ESI-MS. © 2023 Shanghai Institute of Pharmaceutical Industry. All rights reserved.

引用

页码：1182 / 1186

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