Abstract: | Objective To optimize the crystallization process of cefpirome sulfate, reduce the color level, and increase the content of the product. Methods The effects of decolorization pH value, the amount of activated carbon, acceleration rate of crude product flow, and the amount of crystal seed on the color grade and content of cefpirome sulfate were investigated by the single factor test. The crystallization conditions of cefpirome sulfate were optimized by the orthogonal test, and the process was verified by three batches of experiments. Results The optimized parameters for the crystallization process of cefpirome sulfate were decolorization pH4.0, the dosage of activated carbon 4%, the acceleration rate of crude product flow of cefpirome sulfate 1.5mL/min and the dosage of seed 2%. The results of three batches of validation tests were consistent with the orthogonal test results, and the product quality conformed to the internal control quality standards of enterprises. Conclusion The process is stable and feasible, which can effectively reduce the product color level, increase the content, and produce considerable economic |