外观Appearance 白色至类白色结晶粉末
红外光谱鉴定Infrared spectrometry 和对照品匹配
β-lactose含量assay ≥80.0% (GC)
α-lactose含量assay 20.0% (GC)
水分Water
<1 % (K.F.) >干燥损失Loss on drying
<0.5 % (1 g, 80°C, 2 小时) >重金属Heavy metals (as Pb)
<5 ppm >硫酸盐灰分Sulfated ash
<0.1 % >比旋度Specific rotation [a]20/D +54.4°~ +55.9° (c=10, H2O/NH3)
酸/碱Acidity/alkalinity
<0.4 ml 0.1N NaOH/6g >吸光度实验Absorbance 合格(per Eur. Pharm.)
溶液外观Appearance of solution 合格(per Eur. Pharm.)
微生物污染检测microbial contamination: 合格 (per Eur. Pharm.)
来源Origin:小牛
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