Isolation and Characterization of Process Related Impurities in Anastrozole Active Pharmaceutical Ingredient
نویسنده
چکیده
Três impurezas no intervalo de 0,08%-0,12% por área de pico foram detectadas no ingrediente farmacêutico ativo, anastrazol, por cromatografia líquida de alta eficiência (CLAE) em fase-reversa isocrática. Essas impurezas foram isoladas por prep-CLAE e caracterizadas por CL-EM/EM, CG/EM e dados experimentais de RMN. Com base nos resultados obtidos a partir de diferentes experimentos espectroscópicos, essas impurezas foram caracterizadas como 2,2’-(5-((4H-1,2,4triazol-4-il)metil)-1,3-fenileno)bis(2-metilpropanonitrila) (Impureza I), 2,2’-(5-metil-1,3fenileno)bis(2-metilpropanonitrila) (Impureza II) e 2,2’-(5-(bromometil)-1,3-fenileno)bis(2metilpropanonitrila) (Impureza III).
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