Critical method attributes

Critical method parameters

Flow

Column temperature

Mobile phase-A buffer concentration

Mobile phase-A pH

Mobile phase organic ratio

Injection volume

Resolution between Impurity C and B

High

High

Low

High

Low

Low

Resolution between Impurity DABE and H

Medium

Medium

Low

Medium

Low

Low

DABE RS Standard Tailing Factor

Medium

Medium

Low

Medium

Low

Low

DABE AY Standard Tailing Factor

Medium

Medium

Low

Medium

Low

Low

DABE AY Theoretical Plates

Medium

Medium

Low

Medium

Low

Low