Yang Dezhi, Wang Fengfeng, Zhang Li, Gong Ningbo, Lv Yang
Beijing Key Laboratory of Polymorphic Drugs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China.
Acta Pharm Sin B. 2015 May;5(3):231-7. doi: 10.1016/j.apsb.2015.03.009. Epub 2015 Apr 8.
This study compares the results of three certified methods, namely differential scanning calorimetry (DSC), the mass balance (MB) method and coulometric titrimetry (CT), in the purity assessment of ferulic acid certified reference material (CRM). Purity and expanded uncertainty as determined by the three methods were respectively 99.81%, 0.16%; 99.79%, 0.16%; and 99.81%, 0.26% with, in all cases, a coverage factor (k) of 2 (P=95%). The purity results are consistent indicating that the combination of DSC, the MB method and CT provides a confident assessment of the purity of suitable CRMs like ferulic acid.
本研究比较了三种经认证的方法,即差示扫描量热法(DSC)、质量平衡(MB)法和库仑滴定法(CT),用于阿魏酸标准物质(CRM)纯度评估的结果。三种方法测定的纯度和扩展不确定度分别为99.81%,0.16%;99.79%,0.16%;以及99.81%,0.26%,在所有情况下,包含因子(k)均为2(P = 95%)。纯度结果一致,表明DSC、MB法和CT的组合能够可靠地评估阿魏酸这类合适的标准物质的纯度。