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-methionine 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.
LIU Jing-kun, ZHANG Dou-sheng, FAN Hui-hong, LIAO Hai-ming
. Establishment of the first batch of national drug reference standard of L-methionine sulfoxide*[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(8)
: 1373
-1378
.
DOI: 10.16155/j.0254-1793.2023-0311
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