Why is the limit of enalapril impurity D (diketopiperazine) higher than the qualification threshold in ICH Q3B?

In British Pharmacopoeia, the limit of Enalapril impurity D is 1%. However, in ICH has specified that with Maximum Daily Dose 10-100mg (Enalapril Maleat is 40mg), Qualification Threshold would be...

19 November 2023 1,195 1 View