Soluble in 10% sodium hydroxide solution. Slightly Soluble in methanol. Insoluble in water
Conform 符合规定
IDENTIFICATIONS 鉴别
Infrared Absorption 红外
Conform 符合规定
Chloride氯化物
Conform 符合规定
TESTS
检测
Loss on drying干燥失重
≤0.5%
0.3%
Residue on ignition炽灼残渣
≤0.1%
0.04%
Heavy metals重金属
≤10ppm
Conform 符合规定
Related substances
有关物质
Raloxifene ImpurityⅠ 有关物质Ⅰ
≤0.03 %
0.01%
Any unspecified individual impurity Ⅱ
单个未知有关物质Ⅱ
≤0.03%
Max.最大0.02%
Total impurities总有关物质
≤0.30%
0.15%
ASSAY 含量
Raloxifene HCl 盐酸雷洛昔芬
≥99.0%
99.6%
Conclusion: The results conforms with USP 32
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