质量标准
99%:
外观Appearance 白色结晶或结晶粉末
红外光谱鉴别Infrared spectrometry 和对照品匹配
纯度Purity ≥99.0% (HPLC)
熔点Melting point 108°C - 113°C
比旋光度Specific rotation [a]20/D +4.5° ~ +6.5°(c=2, H2O)
水溶解试验Solubility in Water 溶液透明
灰分Ash <0.5 %
品级Grade 细胞培养级
(for cell culture tested, ≥99.0% (HPLC))
外观Appearance 白色至类白色粉末
红外光谱鉴别Infrared spectrometry Conforms to standard
纯度Purity ≥99.0% (HPLC)
水溶解试验solubility in water clear,colorless,100 mg plus 1 ml of water
水分water ≤3%(K.F)
细胞培养测试Cell culture test pass
品级Grade 药用级
(USP, EP, ≥98.5%)
appearance white crystalline powder
ir spectrum consistent with structure
Infrared spectrometry Conforms to standard
assay (dry basis) 98.5 to 101.0%
solubility in water 0.5 G /10 ML in water, clear, colorless
Specific rotation [a]20/D +21.3°~ +27.0°(C=5, Phosphate buffered saline)
zinc content ≤10 ppm
heavy metals ≤10 ppm
loss on drying ≤1.00%
residue on ignition ≤0.20%
l-cystine ≤0.5%
l-cysteine ≤0.5%
n,n'diacetyl-l-cystine ≤0.5%
n,s-diacetyl-l- cysteine ≤0.5%
other impurities ≤0.5% (each)
total impurities ≤0.5%
organic volatiles impurities conforms by certification
ph test 2.0 to 2.8 (1g in 100ml water)
endotoxin assay ≤1 eu/mg
biochemical toxicity passes
note meets usp, ep requirements