The invention discloses a preparation method of gadotec acid
meglumine. The gadotec acid
meglumine is prepared by taking
DOTA,
gadolinium oxide and
meglumine as raw materials. Wherein the related substances in the
DOTA meet the following conditions in percentage by
mass: less than or equal to 0.05% of
impurity RM, and / or less than or equal to 0.05% of
impurity P01, less than or equal to 0.05% of
impurity P02, less than or equal to 0.05% of impurity P03, less than or equal to 0.05% of impurity P04 and less than or equal to 0.5% of total impurities. The invention also relates to the
bulk drug prepared by the preparation method and a
high performance liquid chromatography detection method thereof. On the basis of deep research, according to consideration factors such as the importance degree of each quality index and / or the difficulty degree of removing one or some impurities, key
process conditions or parameters for preparing gadadotec acid meglumine are finally found out and determined; product
quality management and / or control of the production source and even the whole process of the gadadotec acid meglumine
bulk drug are / is really realized and strengthened, and the medication safety of vast patients is better guaranteed.