Prediction of the Shelf Life of Compound Sodium Citrate Injection by Initial Average Rate Stability Test / 中国药房

ABSTRACT

OBJECTIVE:To predict the shelf life of compound sodium citrate injection by initial average rate stability test. METHODS: The initial average rate stability test was performed at 7 different temperatures to investigate the relationship between the initial average rate (V0) of the glucose degradation reaction and Kelvin's temperature (1/T), and the activation energy of reaction, the drug reaction velocity constant and shelf life were computed as well. RESULTS: The regression equation was lgV0=18.15—6 774.6?1/T(r=—0.937 5), the reaction activation energy was 31.0Kcal?mol-1, the drug reaction velocity constant at 20℃ was 1.1?10-5h-1, and the shelf life was 1.09 years. CONCLUSION: The method is simple and it can accurately predicate the shelf life of compound sodium citrate injection.