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Development of a Certified Reference Material for Lyophilized Vitamin K1 |
ZHANG Xiao-guang1,HUANG Ting2,ZHANG Wei2,HUANG Liang3, QUAN Can2,LI Hong-mei2,YANG Yi1 |
1. College of Science, Beijing University of Chemical Technology, Beijing 100029, China;
2. National Institute of Metrology, Beijing 100029, China;
3. Guangzhou Institute of Measuring and Testing Technology, Guangzhou, Guangdong 510030, China |
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Abstract Dimethyl sulfone (DMSO) is firstly applied as the solvent for a lyophilized certified reference material (CRM). Vitamin K1/DMSO solution is prepared by gravimetry, and is sub-divided and lyophilized, the lyophilized vitamin K1 CRM is developed through qualitative analysis, quantitative analysis, homogeneity study, stability study and uncertainty evaluation. Certified value of lyophilization vitamin K1 is analyzed by high performance liquid chromatography method, using the vitamin K1 purity CRM as a calibrant. The certified value is 0.96 mg/mL, with the relative expanded uncertainty of 7%. The method of CRM lyophilized vitamin K1 makes great significance for the accurate determination the disease in clinical examination and the long-term preservation of vitamin K1.
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