項目Item

測試標(biāo)準(zhǔn)Test Criterion

外觀Appearance

白色結(jié)晶粉末

white crystalline powder

含量Assay

Min 99.0%

異構(gòu)體 L-Isomer Content

Max 0.2%

單個雜質(zhì) Single impurity(HPLC)

Max 0.2%

比旋度Specific Rotation

+30.5º to +32.5º (C=1, H₂O 24 ºC)

干燥失重Loss on drying

≤0.50%

其他氨基酸Other amino acids（HPLC）

Max 0.01%

PH value

5.4-6.4

灼燒殘渣Residue on ignition

≤0.10%

Chloride(Cl)                          

≤0.020%

Ammonium(NH4)                    

≤0.020%

Sulfate(SO4)                            

≤0.020%

Iron(Fe)                             

≤20ppm

Heavy metals(Pb)                  

≤10ppm

Arsenic(As2O3)                     

≤1ppm