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