MOXIFLOXACIN FORCED DEGRADATION

Stress Condition

Reagent Used

Conc.

Purity Angle

Purity Threshold

Acid Stress

HCl

0.1N

0.120

0.271

Alkali Stress

NaOH

0.1N

0.124

0.274

Peroxide Stress

H2O2

3%

0.138

0.297

Water Stress

Water

 

0.140

0.277

Heat Stress

Heater

60°C

0.118

0.272

U.V. Stress

Photolytic
chamber

1 Week

0.170

0.278

Acceptance Criteria

Peak Purity shall pass

Table 2: