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目的:确证硫普罗宁注射液中2个较大杂质的结构。方法:利用HPLC和LC-MS等方法确证结构。结果:确证两未知杂质结构为:2-巯基丙酸和N-(2-氯丙酰基)-甘氨酸。结论:2个杂质的结构确定,为硫普罗宁生产工艺的改进及选择合适的运输、储存条件提供了重要信息。
Objective: To confirm the structure of two large impurities in tiopronin injection. Methods: The structures were confirmed by HPLC and LC-MS. Results: Two unknown impurity structures were confirmed: 2-mercaptopropionic acid and N- (2-chloropropionyl) -glycine. Conclusion: The structural determination of two impurities provides important information for the improvement of the production process of tiopronin and the selection of suitable transport and storage conditions.