左乙拉西坦 Levetiracetam

   102767-28-2

 性状 Appearance  白色或类白色结晶性粉末 A white or almost white crystalline powder

鉴别 Identification   

   1. 异构体 Enantiomeric purity:对应异构体应符合规定 It shall comply with the test for Enantomeric purity. 

   2 .红外鉴别 IR:本品的红外吸收图谱应与左乙拉西坦对照 品的图谱一致 IR spectra of sample exhibit similar vAth Levetiracetam standard spectra

溶液 Solution  溶液应澄清，且颜色不得深于 BY6对照液 the solution is clear (2.2.1) and not more intensely coloured than reference solution BY6 (2.2.2).

水分 Water  ≤0.5%

异构体 Enantiomeric Purity   ≤0.8

硫酸盐灰分 Sulphated ash  ≤0.1%

有关物质 Related substances 

 杂质 A Impurity A≤0.3% 

其它单杂 Any other individual impurity≤0.05% 

总杂质 Total impurities≤0.4%

含量 Assay  98.5%-102%

残留溶剂 Residual solvent   二氯甲烷 Methylene chloride≤600ppm 乙酸乙酯 Ethyl acetate≤5000ppm

结论 Conclusion  本品按最新 EP 标准检测，结果符合规定。 It comphes with all the requirements of current EP monograph.