Establishment of the first batch of national drug reference standard of L-methionine sulfoxide
Objective:To establish the first batch of national drug reference standard of L-methionine sulfoxide.Methods:The molecular structure of methionine sulfoxide was confirmed by the methods of IR,NMR and high resolution MS.Moreover,the moisture,residual solvents,residual ignition and related substances of L-methio-nine sulfoxide were determined,and then,its hygroscopicity,homogeneity and stability were also observed.Finally,mass balance method,HPLC and quantitative NMR were applied to determine and calculate its contents.Results:The results of experiments showed the structure of L-methionine sulfoxide were confirmed,its contents of moisture,residual ignition,metal elements and related substances were 0.23％,0.20％,10.87 μg·g-1 and 5.09％.The residual solvents were not detected in the samples.The final content of methionine sulfoxide was 94.5％by mass balance method.The contents of this batch of L-methionine sulfoxide were uniform,and it is stable in short-terms.Conclusion:The first batch of national drug reference standard of L-methionine sulfoxide was established,and it is used for the inspection for related substances of amino acid drug,which is helpful in normalizing drug quality and guaranteeing drug safety.
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