達蘆那韋乙醇合物
635728-49-3
白色至類白色粉末.White to almost white powder
HPLC鑒別: 在對映異構體測定項下主峰的保留時間應與對照品保留時間一致 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%
對映異構體Enantiomeric impurity ≤0.3%
有關物質Related substances (HPLC) ≤0.08%
雜質Aimpurity A ≤0.08%
雜質Bimpurity B| ≤0.08%
單個雜質Individual impurity ≤0.08%
總雜質Total impurities ≤0.5%
結論Conclusion 本品按企業標準檢測，結果符合規定。It complies with all the requirements of enterprise standard .
