Stress condition Conc. μg/mL %Degradation Major degradant Purity angle Purity Threshold Mass balance
Non stressed 512 - - 0.10 2.2 100
Acid hydrolysis 495 12.6% Imp-A&C 0.15 2.45 99.2
Base hydrolysis 502 18.1% Imp-A&C 0.22 3.22 98.8
Oxidation 515 3.2% Imp-A 0.25 2.66 99.1
Heat and humidity 501 No significant 9.11 0.19 1.72 99.2
Photo stability 511 No significant 8.22 0.26 3.55 99.4
Dry heat 509 5.4% Imp-A `0.13 3.75 99.7
Table 6: Forced degradation studies.