摘要
目的建立首批脱苏氨醇8奥曲肽对照品。方法应用红外光谱、基质辅助激光解析飞行时间质谱、氨基酸序列分析等对脱苏氨醇8奥曲肽进行结构确证,采用HPLC法测定纯度、检测醋酸含量及氨基酸比值。结果确证了脱苏氨醇8奥曲肽原料的结构,并确定其含量为85.9%。结论首批脱苏氨醇8奥曲肽对照品(批号:140795-201001)的建立便于对奥曲肽杂质进行定性控制。
Objective To establish a national reference standard for des-Thy-ol8-octreotide.Methods IR,MALDI-TOF and Amino Acid Sequence Analysis were used to confirm the structure of des-Thy-ol8-octreotide.HPLC was applied to determine the purity,the content of acetic acid and the ratio of amino acid.Results The structure of the material was confirmed and the content was 85.9%.Conclusion The established national reference standard of des-Thy-ol8-octreotide（Batch No 140795-201001） can efficiently control the quality of des-Thy-ol8-octreotide in octreotide.
出处
《中国药事》
CAS
2012年第11期1197-1199,共3页
Chinese Pharmaceutical Affairs
