质量标准:外观Appearance 白色结晶或粉末
纯度Purity ≥99.0% (HPLC)
比旋光度Specific rotation [a]20/D +23.5° ~ +25.5°(c=2, 6 N HCl)
干燥损失Loss on drying <0.5 % (1 g, 105°C)
重金属Heavy metals (as Pb) <10 ppm
硫酸盐灰分Sulfated ash <0.1 %
pH 5.5 - 6.5 (2.5% 水溶液, 25°C)
品级Grade 药典级
(Meets USP, EP, and JP )
Appearance White Powder
Identity by IR Conforms to Structure
Solubility (Color) Clear,2.5g to 100 mL H2O
Specific rotation [a]20/D 23.0 - 24.0 °
EP/JP: c = 2 in 6M HCl
Specific rotation [a]25/D 22.4 - 24.7 °
USP: c = 2 in 6M HCl
Chloride ≤ 0.020%
Ammonium ≤0.02%
Sulfate ≤ 0.020%
Iron (Fe) ≤ ppm
Heavy Metals(Lead) ≤ 10 ppm
Arsenic (As) ≤ 2 ppm
Loss on Drying ≤0.20 %
Residue on Ignition ≤0.10 mg
Residual Solvents USP <467> Meets Requirements
Expected Solvent Residual Solvent Meets Requirements
Ninhydrin-Positive Substances Conforms
pH JP/EP 5.5 - 6.2
EP/JP: 2.5%, H2O, 20 deg C
pH 5.6 - 6.1
USP: 1%, H2O, 25 deg C
Assay (Dry Basis) 99.0 - 101.0 %
Endotoxin Assay ≤1.0 EU/mg
Cell Culture Test Pass
Cell Line Attached Cell Line