項目 Items 標準參數(shù) Specifications 結果 Results 外觀 Appearance White or slight grety powder Complies 鑒別 Identification H-1 NMR spectrum Complies 單個雜質(HPLC) Individual impurity <0.5% 0.14% 總雜 Total impurity(HPLC) <1% 0.35% 熔點 Melting point 129.0-132.0℃ 129.5-130.7℃ 干燥失重 Drying loss ≤0.5% 0.06% 含量 Assay (HPLC) ≥99.0% 99.65% 結果 Results The product conforms to the above specifications
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