Zoglio M A, Maulding H V, Streng W H, Vincek W C
J Pharm Sci. 1975 Aug;64(8):1381-3. doi: 10.1002/jps.2600640826.
A continuous nonisothermal-isothermal method for stability prediction was developed. The approach yields all necessary parameters for prediction, including reaction order. The experimental procedure involves changing the temperature of the samples being studied until degradation is rapid enough to proceed at a convenient isothermal rate for a sufficient number of half-lives with adequate analytical sensitivity so that the reaction order can be unambiguously determined. The analytical information obtained during the nonisothermal and isothermal portions of the experiment is utilized without curve matching in calculating the activation energy and determining the reaction order, reaction rate, and stability prediction at any desired temperature. Model experiments include the acid-catalyzed hydrolysis of acetylcholine bromide and the inversion of sucrose.
开发了一种用于稳定性预测的连续非等温-等温方法。该方法可得出预测所需的所有参数，包括反应级数。实验步骤包括改变被研究样品的温度，直至降解速度足够快，以便能以方便的等温速率进行足够数量的半衰期反应，同时具备足够的分析灵敏度，从而能够明确确定反应级数。在计算活化能以及确定任何所需温度下的反应级数、反应速率和稳定性预测时，无需进行曲线拟合即可利用在实验的非等温部分和等温部分获得的分析信息。模型实验包括溴化乙酰胆碱的酸催化水解和蔗糖的转化。
