Preparation method of tofogliflozin oxidation impurities
The invention discloses a preparation method of tofogliflozin oxide impurities and three related impurities. The preparation method is simple, the purity is high, raw materials are simple and easy to obtain, and a qualified impurity reference substance can be provided for quality control of tofoglif...
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Format: | Patent |
Sprache: | chi ; eng |
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Zusammenfassung: | The invention discloses a preparation method of tofogliflozin oxide impurities and three related impurities. The preparation method is simple, the purity is high, raw materials are simple and easy to obtain, and a qualified impurity reference substance can be provided for quality control of tofogliflozin. The invention provides a new reference substance for detection of degradation impurities of tofogliflozin bulk drugs and related preparations, is more beneficial to process research and quality control, further controls the product quality of tofogliflozin, and has great significance and practical value.
本发明公开了托格列净氧化杂质的制备方法及涉及到的三种杂质,该制备方法简单、纯度高、原料简单易得,能够为托格列净的质量控制提供合格的杂质对照品。本发明为托格列净原料药及相关制剂的降解杂质检测提供了新的对照品,更有利于工艺研究和质量控制,进而控制托格列净的产品质量,具有重大的意义和实用价值。 |
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