那西肽预混剂质量分析
发布时间：2019-05-11 10:24
【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;调整了p H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。
[Abstract]:Through the test and research of naciditide premix, the quality of nacitide premix was analyzed, and the existing standards were revised. According to the existing standards, the conventional test of naciditide premix was carried out, and the standard was revised and the key points of quality control were determined. According to the literature retrieval and investigation, the content uniformity, Naxi peptide component A and content determination were explored and studied. It is suggested that the stipulation on traits in the standard should be abolished, the limit range of pH value should be adjusted to 6.0 鈮，
本文编号：2474415
[Abstract]:Through the test and research of naciditide premix, the quality of nacitide premix was analyzed, and the existing standards were revised. According to the existing standards, the conventional test of naciditide premix was carried out, and the standard was revised and the key points of quality control were determined. According to the literature retrieval and investigation, the content uniformity, Naxi peptide component A and content determination were explored and studied. It is suggested that the stipulation on traits in the standard should be abolished, the limit range of pH value should be adjusted to 6.0 鈮，
本文编号：2474415
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