Quality Standard: 外觀Appearance 白色至黃色結(jié)晶或結(jié)晶粉末
純度Purity (以干基計(jì)) >98.0% (HPLC)
水分Water <2 % (K.F.)
重金屬Heavy metals (as Pb) <10 ppm
比旋光度Specific rotation [a]20/D +30°~ +32°(c=1, 0.1 N NaOH) (以干基計(jì))
吸光率Ratio of Absorbances 0.47 - 0.53 (A250/A260) (pH 2)
1.87 - 1.93 (A280/A260)
1.45 - 1.55 (A290/A260)
相關(guān)物質(zhì)related substances (HPLC):
5-溴尿嘧啶5-bromouracil: < 0.5%(HPLC)
不明物雜質(zhì)each unknown impurity: < 0.2% (HPLC)
總雜質(zhì)total impurities: < 2.0%(HPLC)
溶劑殘?jiān)黂esidual solvents <0.2 % 乙醇 (GC)
<0.1 % 甲醇(GC)
微生物總數(shù)total microbial count: 符合 (< 100 CFU/g)
細(xì)菌內(nèi)毒素測(cè)試bacterial endotoxins test: < 0.1 EU/mg(LAL-test)