Guidance Document: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) - ICH Topic Q11 - Figure 3 Text Description: Hydrolysis Degradation at Reflux

Xy axis graph

Y axis is Hydrolisis Impurity (%) in Intermediate F, x axis is Reflux Time (hours)

First line starts at (0,0) with round dots at each point indicating 0.5%. The first point is at (1.0,0), second point at (2.0, 0.05), third point at (3.0, 0.075), fourth point at (4.0,0.1).

Second line starts at (0,0) with diamonds at each point indicating 2.0%. The first point is at (1.0,0.15), second point at (2.0, 0.30), third point at (3.0, 0.40), fourth point at (4.0,0.60).

Third line starts at (0.25,0) with squares at each point indicating 1.5%. The first point is at (1.0,0.10), second point at (2.0, 0.20), third point at (3.0, 0.30), fourth point at (4.0,0.40).

Fourth line starts at (0.25,0) with triangles at each point indicating 1.0%. The first point is at (1.0,0.05), second point at (2.0, 0.15), third point at (3.0, 0.20), fourth point at (4.0,0.30).