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HPLC法分析头孢唑林钠的TGA热降解残留物,发现其中的主要热降解物和头孢唑林钠在固体贮存中产生的主要降解物相同,提示二者的分解途径相似。据此,利用TGA测定热降解动力学的方法,建立了评价头孢唑林钠固体相对稳定性的方法。虽然头孢唑林钠的热降解反应是一复杂的反应过程,但选择1%的降解水平(conversionlevel)进行评价可得出和常规加速试验相似的结果。利用建立的评价方法,对头孢唑林钠的三种不同结晶型(α型、脱水α型和无定型)产品的相对稳定性进行评价,发现其α型样品的相对稳定性最好,无定型样品的相对稳定性最差。
HPLC analysis of cefazolin sodium TGA thermal degradation residues and found that the main thermal degradation of cefazolin sodium and solid storage in the same major degradation products, suggesting that the decomposition of the two similar ways. Based on this, the method of TGA determination of thermal degradation kinetics was established to evaluate the relative stability of cefazolin sodium. Although the thermal degradation reaction of cefazolin sodium is a complicated reaction process, the choice of 1% conversionlevel for evaluation gives similar results to those of conventional accelerated tests. The relative stability of three different crystal forms of cefazuolin sodium (α-type, dehydrated α-type and amorphous) was evaluated by the established evaluation method. The relative stability of α-type sample was found to be the best, The relative stability of the sample is the worst.