质量标准: 外观Appearance 白色结晶粉末或结晶
红外光谱鉴别Infrared spectrometry 和对照品匹配
纯度Purity >98.0%
干燥损失Loss on drying <0.2 % (105°C, 3 小时)
重金属Heavy metals (as Pb) <10 ppm
硫酸盐灰分Sulfated ash <0.1 %
pH 4.7 - 6.2 (2.5% 溶液, 25°C)
其它氨基酸Other amino acids <0.5 % (TLC)
比旋度Specific rotation [a]20/D +21.4° - +23.6°(c=8, 6 N HCl)
痕量分析Trace analysis :
SO4 < 300 ppm
NH4 < 200 ppm
Fe < 10 ppm
透光度Transmittance >95 % (c=10, H2O, 430 nm) 1 cm cell
USP级
ASSAY (DRIED BASIS) 98.5 - 101.5 %
SPECIFIC ROTATION [a]D +21.4 TO+23.6
LOSS ON DRYING -- 0.2 %
CHLORIDE CONTENT 16.5 - 17.1 %
RESIDUE ON IGNITION -- 0.1 %
SULFATE -- 0.03 %
HEAVY METALS -- 0.002 %