Preparation method of ulipristal acetate impurity reference substance

• Main Authors: LIU XIRONG, XIE ZUOYI, ZENG CHUNLING, JIN ZHIZHONG
• Format: Patent
• Language: Chinese; English
• Published: 08.01.2021
• Subjects: CHEMISTRY; INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; METALLURGY; ORGANIC CHEMISTRY; PHYSICS; STEROIDS; TESTING

The invention belongs to the technical field of steroid hormone drug preparation, and particularly relates to a preparation method of an ulipristal acetate impurity reference substance; the ulipristalacetate impurity reference substance is obtained by catalytic reaction of ulipristal acetate through an acid catalyst under the action of an esterification reagent, and the ulipristal acetate impurity reference substance is 17[alpha]-acetoxy-3-acetoxy-11[beta]-[4-(N,N-dimethylamino)]phenyl]estrogen-3,5(10),9(11)-trien-20-one; the esterification reagent is isopropenyl acetate or acetic anhydride,the acidic catalyst is p-toluenesulfonic acid, methanesulfonic acid or trifluoromethanesulfonic acid, the product purity is high, the yield is high, the generation of other impurities can be effectively inhibited, and the product is used as a reference substance in an ulipristal acetate production process and is used for controlling the quality of ulipristal acetate. 本发明属于甾体激素药物制备技术领域，具体涉及一种醋酸乌利司他杂质对照品的制备方法，将醋酸乌利司他在酯化试剂作用下