Research Article

Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation

Table 5

Incompatibility study of pramipexole and its excipients.

Sample IDConditionUnknown imp (RRT∼0.7)

PramipexoleW2 40°CND
W4 40°CND

Mixture of pramipexole + mannitolW2 40°C0.04
W4 40°C0.38

Mixture of pramipexole + low hydroxypropyl celluloseW2 40°CND
W4 40°CND

Mixture of pramipexole + colloidal anhydrous silicaW2 40°CND
W4 40°CND

Mixture of pramipexole + Mg stearateW2 40°CND
W4 40°CND