目前对药物纯度的要求越来越严格。作者设计了一种准确而简便的定量方法,用于分析药物中酸-碱杂质,尤其适用于利用中和法生产的强酸或强碱盐的药物中酸-碱杂质的测定。本法系测定酸-碱杂质的新的电位法。由于方法准确、快速和简便,使本法既可适于药典常规分 At present the requirements for the purity of the drug are more and more strict. The authors designed an accurate and simple quantitative method for the analysis of acid-base impurities in pharmaceuticals, especially for the determination of acid-base impurities in pharmaceuticals using strong acids or strong base salts produced by the neutralization method. This method is a new potentiometric method for the determination of acid-base impurities. Because of the accuracy, speed and simplicity of the method, this method can be adapted to the routine pharmacopoeia