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Purity and Uncertainty Study of CRM Betulin by DSC |
| Li Zhang1, Peng-Hui Yuan1, De-Zhi Yang1, Yan-Cai Bi2, Bin Su2, Bao-Xi Zhang1, Fu-Qing Wang3, Yang Lu1, Guan-Hua Du4 |
1 Beijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, People's Republic of China;
2 Soteria Pharmaceutical Co., Ltd., Laiwu 271100, People's Republic of China;
3 China Pharmaceutical Enterprises Association, Beijing 100044, People's Republic of China;
4 Beijing City Key Laboratory of Drug Target and Screening Research, National Center for Pharmaceutical Screening, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, People's Republic of China |
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Abstract Betulin (BE) can be obtained from many plants, such as those belonging Betulaceae family, and pharmacological investigations showed its notable biological properties and good potential for food and pharmaceutical development. We investigated the homogeneity, stability, purity, and uncertainty of a newly certified reference material (CRM) of BE. The certified purity value for the CRM of BE was 99.56% with an extended uncertainty of 0.07% (k=2, P=0.95), as determined by differential scanning calorimetry (DSC). In this study, DSC was used for the first time for purity determination of BE. Given its high accuracy, precision, and reproducibility, DSC can be used as an alternative technique for purity determination of CRMs in the pharmaceutical and food industry.
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| Keywords
Betulin
DSC
Purity determination
Uncertainty study
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| Fund:This work was financially supported by National Key R&D Program of China (Grant No. 2016YFC1000900), National Science and Technology Major Project of China (Grant Nos. 2017ZX09101001003, 2018ZX09711001-003-022, 2018ZX09711001-010), National Natural Science Foundation of China(NSFC) (Grant No. 81703473) and CAMS Innovation Fund for Medical Sciences(Grant No. 2017-I2M-3-010). |
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Corresponding Authors:
Fu-Qing Wang
E-mail: wangfuqingwfq@163.com
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Issue Date: 23 October 2020
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