达芦那韦乙醇合物
635728-49-3
白色至类白色粉末.White to almost white powder
HPLC鉴别: 在对映异构体测定项下主峰的保留时间应与对照品保留时间一致 Retention time of major peak of sample solution corresponds to that of standard solution, as obtained in the Enantiomeric impurity by HPLC.
水分water ≤0.3%
对映异构体Enantiomeric impurity ≤0.3%
有关物质Related substances (HPLC) ≤0.08%
杂质Aimpurity A ≤0.08%
杂质Bimpurity B| ≤0.08%
单个杂质Individual impurity ≤0.08%
总杂质Total impurities ≤0.5%
结论Conclusion 本品按企业标准检测,结果符合规定。It complies with all the requirements of enterprise standard .