The color grade, mainly introduced in the processes of semisynthesis and storage, is an important index used to evaluate the quality of cefotaxime sodium. Because the drug itself is prone to degradation under susceptible conditions, including those involving moisture, heat, ultraviolet light, acids, alkalis, and oxidants, and a series of degradation products as impurities are generated. In this study, the factors affecting color grade stability and the degradation mechanisms of cefotaxime sodium were investigated by designing different accelerated stability tests under the aforementioned conditions. The degradation extent was studied by using analytical methods, such as a solution color comparison method, ultraviolet spectrophotometry, and HPLC. The relationship between the color grade stability of cefotaxime sodium and its impurity profile has been explored, and a reasonable degradation mechanism has been proposed. The manufacturing conditions of inspection have been optimized, and a scientific basis for drug packaging, storage, and transportation conditions has been established. The results show that the color grade stability of cefotaxime sodium is related to the impurity profile to some degree, and the difference between the actual color and the standard color can reflect the levels of impurities to some extent.

主要在半合成和储存过程中引入的颜色等级是用于评估头孢噻肟钠质量的重要指标。因为药物本身容易在易受影响的条件下降解，包括涉及水分，热量，紫外线，酸，碱和氧化剂的条件，并且会生成一系列降解产物（作为杂质）。在这项研究中，通过设计在上述条件下不同的加速稳定性试验，研究了影响颜色等级稳定性的因素和头孢噻肟钠的降解机理。使用溶液颜色比较法，紫外分光光度法和HPLC等分析方法研究降解程度。探索了头孢噻肟钠的色级稳定性与其杂质分布之间的关系，并提出了合理的降解机理。优化了检查的制造条件，并建立了药品包装，储存和运输条件的科学依据。结果表明，头孢噻肟钠的色度稳定性在一定程度上与杂质谱有关，实际颜色和标准颜色之间的差异可以在一定程度上反映杂质含量。