质量标准
99%:
外观Appearance 白色粉末
红外光谱鉴别Infrared spectrometry 和对照品匹配
纯度Purity ≥99% (以干基计)
干燥损失Loss on drying <0.5 % (105°C, 3 小时)
重金属Heavy metals (as Pb) <10 ppm
硫酸盐灰分Sulfated ash <0.1 %
其它氨基酸Other amino acids 未检测到
比旋度Specific rotation [a]20/D +30.5°~ +32.5°(以干基计) (c=10, 2N HCl)
痕量分析Trace analysis :
Cl < 200 ppm
Fe < 30 ppm
SO4 < 300 ppm
NH4 < 200 ppm
As2O3 < 1 ppm
品级Grade 超纯级, ≥99.5% (NT)
外观Appearance 白色粉末
红外光谱鉴别Infrared spectrometry 和对照品匹配
纯度Purity((NT) ≥99.5%
比旋光度Specific rotation [α]20/D +31.5±1.0°, c = 5% in 5 M HCl
不溶物insoluble matter, passes filter test
外源氨基酸foreign amino acids ≤0.5%
灼烧残渣Residue on ignition(as SO4) ≤0.05%
干燥损失loss on drying, 20 °C (HV) ≤0.05%
盐酸溶解实验solubility 1 M HCl: soluble1 M at 20 °C, clear, colorless
氯chloride (Cl-): ≤100 ppm
硫酸根sulfate (SO42-): ≤200 ppm
cation traces Al: ≤5 ppm
Ba: ≤5 ppm
Bi: ≤5 ppm
Ca: ≤200 ppm
Cd: ≤5 ppm
Co: ≤5 ppm
Cr: ≤5 ppm
Cu: ≤5 ppm
Fe: ≤5 ppm
K: ≤50 ppm
Li: ≤5 ppm
Mg: ≤5 ppm
Mn: ≤5 ppm
Mo: ≤5 ppm
NH4+: ≤100 ppm
Na: ≤200 ppm
Ni: ≤5 ppm
Pb: ≤5 ppm
Sr: ≤5 ppm
Zn: ≤5 ppm
λ 1 M in 1 M HCl
UV absorption
λ: 260 nm A: ≤0.1
λ: 280 nm A: ≤0.1
品级Grade 非动物源,EP, JP, USP ;用于细胞培养,98.5 to 101.0%
(from non-animal source, EP, JP, USP, for cell culture, 98.5 to 101.0%)
来源origin non-animal source
外观appearance white crystalline powder
红外鉴别试验identification by ir compares to reference standard
盐酸溶解试验solubility Colorless,Clear ,1.0 g to 10 ml of 2 M HCl
比旋光度specific rotation 31.5 - 32.4 °
(C = 10 in 2 M HCl at 20 deg C)
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 ≤ 0.10%
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 3.0 to 3.5 (1% in water)
含量assay (dry basis) 98.5 to 100.5%
内毒素endotoxin assay ≤ 1 eu/mg
细胞培养测试cell culture test pass