Method Improving for Isolation and Characterization of Allergy-Inducing Polymer Impurities in Cefotaxime Sodium Medicines Available From Pharmaceutical Industry.

ABSTRACT: Objective: To prepare and validate the chemical structure of the cefotaxime dimer and cefotaxime trimer impurities available from pharmaceutical industry. Methods: A polymer stock solution of cefotaxime sodium was obtained using a concentrated solution degradation method. The cefotaxime dimer and trimer impurities were separated and purified by preparative reversed-high-performance liquid chromatograph (RP-HPLC), and the pure cefotaxime dimer and trimer were obtained by a freeze-drying method. The two impurities were characterized by infrared (IR) spectroscopy, ultraviolet (UV) spectroscopy, mass spectroscopy, and nuclear magnetic resonance (NMR, including one-dimensional and two-dimensional NMR). The groups corresponding to the characteristic absorption peaks in the UV and I

SUBMITTER: Fu Y 

PROVIDER: S-EPMC8918496 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature