首批N(2)-L-丙氨酰-L-谷氨酰胺国家对照品的研制

Development of First Batch of National Reference Standard of N(2)-L-alanyl-L-glutamine

目的建立首批N(2)-L-丙氨酰-L-谷氨酰胺国家对照品。方法应用红外光谱、液质联用仪等对N(2)-L-丙氨酰-L-谷氨酰胺进行结构确证,采用HPLC法测定纯度及氨基酸比值,采用3种方法进行含量测定。结果确定首批N(2)-L-丙氨酰-L-谷氨酰胺对照品的含量为99.8%。结论首批N(2)-L-丙氨酰-L-谷氨酰胺国家对照品可用于N(2)-L-丙氨酰-L-谷氨酰铵及其制剂的定性和定量控制。

Objective To establish the first batch of the national reference standard of N （2）- L-glutamine. Methods The IR spectrometer and LC-MS were used to confirm the structure of N alanyl-L-glutamine. HPLC was used to determine the purity and the ratio of amino acid. Three methods were used to detect the content of N （2） -L-alanyl-L-glutamine. Results The structu first batch of the national reference standard of N （2） -L-alanyl-L-glutamine was confirmed content was 99.8%. Conclusion The first batch of the national reference standard of N （2） -L- glutamine can be used for quality and quantity controls of N （2）-L-alanyl-L-glutamine preparatmns. L-alanyl- （2） -L- kinds of re of the and the alanyl-L- and its