左乙拉西坦 Levetiracetam
102767-28-2
性狀 Appearance 白色或類白色結晶性粉末 A white or almost white crystalline powder
鑒別 Identification
1. 異構體 Enantiomeric purity:對應異構體應符合規定 It shall comply with the test for Enantomeric purity.
2 .紅外鑒別 IR:本品的紅外吸收圖譜應與左乙拉西坦對照 品的圖譜一致 IR spectra of sample exhibit similar vAth Levetiracetam standard spectra
溶液 Solution 溶液應澄清，且顏色不得深于 BY6對照液 the solution is clear (2.2.1) and not more intensely coloured than reference solution BY6 (2.2.2).
水分 Water ≤0.5%
異構體 Enantiomeric Purity ≤0.8
硫酸鹽灰分 Sulphated ash ≤0.1%
有關物質 Related substances
雜質 A Impurity A≤0.3%
其它單雜 Any other individual impurity≤0.05%
總雜質 Total impurities≤0.4%
含量 Assay 98.5%-102%
殘留溶劑 Residual solvent 二氯甲烷 Methylene chloride≤600ppm 乙酸乙酯 Ethyl acetate≤5000ppm
結論 Conclusion 本品按最新 EP 標準檢測，結果符合規定。 It comphes with all the requirements of current EP monograph.
