原文由 quanchaoli 发表:
Pl. note that we are getting one extra impurity peak ( Marked in RED )as earlier problematic consignment at the RT = about 4.30, before Rifa Quinone RT = about 6.25) having more% than Rifa quinone as well as not complying the USP Lim = NMT 1.0%.
我的理解:
请注意,在图谱中有一个额外的杂质峰(红色标记)。该峰为问题峰,保留时间约为4.30,在醌氏利福平的保留时间(约为6.25)之前。其百分比高于醌氏利福平,也不符合美国药典中(杂质峰)不得超过1.0%的要求。
as earlier problematic consignment 和having more% than Rifa quinone as well as not complying the USP Lim = NMT 1.0%都是修饰one extra impurity peak 的。