化学性质
白色斜方晶系或结晶性粉末。无臭,味微甜
熔点 256 °C (dec.)(lit.)
比旋光度 -28.4 o (c=6, H2O)
折射率 -28 ° (C=6, H2O)
溶解度 H2O: 50 mg/mL
质量标准
99%
外观Appearance 白色结晶粉末
红外光谱鉴别Infrared spectrometry 和对照品匹配
纯度Purity ≥99.0% (以干基计)
干燥损失Loss on drying <0.2 % (1 g, 105°C, 3 小时)
重金属Heavy metals (as Pb) <5 ppm
硫酸盐灰分Sulfated ash <0.05 %
比旋度Specific rotation [a]20/D -27.6°~ -29° (c=6, H2O)
痕量分析Trace analysis :
Cl < 100 ppm
SO4 < 100 ppm
溶解性Appearance of solution (2.5% 水溶液.) 无色透明
品级Grade 非动物源,EP, JP, USP ;用于细胞培养,99.0-101.0%
(from non-animal source, EP, JP, USP, for cell culture, 99.0-101.0%)
来源origin must be non-animal source
外观appearance white crystalline powder
红外鉴别试验identification by ir compares to reference standard
水溶解性solubility clear colorless solution at 1g t o 10ml of water
比旋光度specific rotation -27.6 to -29.0 deg (20degc/EP, JP) -26.7 to -29.1 deg (25degc/USP)
氯chloride ≤ 0.020%
铵ammonium ≤ 0.02%
硫酸盐sulfate ≤ 0.020%
铁iron ≤ 10 ppm
重金属heavy metals ≤ 10 ppm
砷arsenic ≤ 1 ppm
干燥失重loss on drying ≤ 0.20%
灼烧残渣residue on ignition ≤ 0.10%
残留溶剂residual solvents meets the requirements
茚三酮阳性物质ninhydrin-positive substances (other amino acids)
conforms
ph test (USP) 5.0 to 6.5 (5% in water)
ph test (EP) 5.0 to 6.5 (2.5% in water)
ph test (JP) 5.2 to 6.2 (1% in water)
含量assay (dry basis) 99.0 to 101.0%
内毒素endotoxin assay ≤ 1 eu/mg
细胞培养测试cell culture test pass