Development of certified reference material of tetrin B
Aims:This paper aims to develop a certified reference material(CRM)of tetrin B according to GB/T 150003-2008"Guidelines for the Work of Standard Samples(3)General Principles and Statistical Methods for Determining the Value of Standard Samples".Methods:Tetrin B was obtained from metabolites of Streptomyces diastatochramo genes 1628 by extraction,AB-8 and Sephardex LH-20 column chromatography.The structure of tetrin B was confirmed by UV,IR,MS and NMR analysis.Subsequently,tetrin B was divided into 100 bottles with 10 mg per bottle.The homogeneity and stability testing and cooperative certification were carried out by HPLC detection.Results:The homogeneity was good within 95% confidence interval by the F test statistical method.The sample was stable within a 12 months storage period at-20~-18 ℃.A cooperative certification was conducted with 8 qualified laboratories;and the certified purity value of tetrin B 99.37% with an expanded uncertainty of 0.22% .Conclusions:The reference material tetrin B conforms to the technical requirement of the certified reference material.The material can be used in the method validation and quality control regarding tetrin B.