主题：【讨论】乙醇挥发性杂质，中国药典与美国药典对比

中国药典：


美国药典：
Chromatographic system (see Chromatography 621)— The gas chromatograph is equipped with a flame-ionization detector, maintained at about 280, and a 0.32-mm × 30-m fused silica capillary column bonded with a 1.8-µm layer of phase G43. The carrier gas is helium with a linear velocity of about 35 cm per second and a split ratio of 1:20. The column temperature is maintained at 40 for the first 12 minutes after an injection is made and is increased from 40 to 240 from 12 to 32 minutes after injection. During the period of 32 to 42 minutes after an injection is made, the column temperature is maintained at 240. The injection port temperature is maintained at 200. Chromatograph Standard solution B, and record the peak responses as directed for Procedure: the resolution, R, between the first major peak (acetaldehyde) and the second major peak (methanol) is not less than 1.5.

两者规定基本一致，美国药典进一步细化规定了色谱柱的规格为30m×0.32mm×1.8μm、载气为氦气、线速度为35cm/s、分流比为1:20。
检验主要问题是，甲醇峰异常拖尾，乙醛峰和甲醇峰分离度在1.5左右。