Baoxi Zhang, Ningbo Gong, Dezhi Yang, Guanhua Du, Zhaolin Gao and Yang Lu Pages 153 - 158 ( 6 )
Certified reference materials (CRMs) play vital roles in method validation and quality assurance of assessment measurements. In this paper, a new CRM for sulfamethoxazole (SMZ) was prepared. Purity determination and uncertainty evaluation methods were developed using mass balance (MB) and differential scanning calorimetry (DSC) methods. Impurities including moisture, volatile components, and inorganic components were accounted for and deducted from 100% using the MB method. Results were consistent between DSC and MB. Certi ed value of SMZ was 991.6 ± 4.6 mg g-1 (k = 2, P = 0.95). This new CRM can be used to validate analytical methods, improve the accuracy and comparability of measurement data, establish metrological traceability of analytical results, and control the quality of SMZ in relevant pharmaceutical formulations.
CRM, purity determination, SMZ, uncertainty evaluation.
Center of Pharmaceutical Polymorph, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.