摘要
通过对那西肽预混剂检验与研究，对其质量进行分析，并对现有标准进行修订。依据现有标准，对那西肽预混剂进行常规检验，对标准进行了修订并确定质量控制关键点；根据文献检索和调研等情况，开展了含量均匀度、那西肽组分A、含量测定等3个方面的探索研究。建议取消标准中关于性状的规定；调整TpH值的规定限度范围为6．0～8．0；补充建立了那西肽组分A的测定方法，拟规定限度为不小于88．0％；以N,N-二甲基甲酰胺为溶剂，修订了那西肽预混剂含量测定方法。
The qualities of nosiheptide premix were comprehensively evaluated. According to the standards, all the samples were examined. We revised the standard and establish the key points in the quality control; carried out study of the content uniformity degree, nosiheptide component A, and content determination. We recommended to delete appearance test, adjust the limits of pH value to 6.0-8.0, and add a method for the determination of the nosiheptide component A. The proposed limits is not less than 88%. N,N-Dimethylformamide was as solvent, revise the method of assay.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2016年第10期767-770,共4页
Chinese Journal of Antibiotics
作者简介
于丽娜，女，生于1986年，助理研究员，从事抗生素等化学药品分析工作。
通讯作者，E-mail：zhaohui_kss@163．com
