Effects Of Storage Condition And Filling Nitrogen On Color Level Of Cefuroxime Sodium API

【Objective】Cefuroxime is an antibiotic with poor stability in color. In this study, weinvestigated the effects of store condition and nitrogen-fill on color change inCefuroxime API.【Methods】194batches sterile cefuroxime from a production process, each batch wassubpackage in16units vases with30g of packaging size,8vases were nitrogen filledcharging during production, and the other8vases were not filled nitrogen,4of8vaseswith two type of packaging were stored in cool condition and half of them were stored incold condition, color changes were observed after3,6and12months (±3days) with onevase for each condition according to method of Chinese Pharmacopeia. Color level wasdefined as <YG1=0.5, YG1=1.0and so on. We aimed to evaluate the color level indifference condition in cold and cool storage, no-nigtrogen and nigtrogen condition.【Results】(1) In the condition of without filling nitrogen,19.1%of raw materials reached thehighest level of color (<YG6) after12month in cool condition; however, only7.2%reached the highest level of color (=YG5) in cold condition;(2) In the condition of filling nitrogen,8.8%of raw materials reached the highestlevel of color (=YG5) after12month in cool condition; however, only2.6%reached the highest level of color (<YG5) in cold condition.【Conclusion】(1) The sterile cefuroxime sodium API were more stability stored in cold conditionthen in cool storage;(2) The sterile cefuroxime sodium API were more stability with nitrogen-fillprotection then in cool storage.