Validation

Controlling Hardware Variables

To achieve reliable and consistent results in dissolution testing it is essential to control many small variables. Some of these variables have been defined in the USP and some have yet to be addressed in the compendium due to a lack of data or agreements about how they can be measured.

Important variables include:

• Wobble
• Vibration
• Shaft Centering
• Basket & Paddle Height
• Shaft RPM
• Vessel Validation
• Bath Level
• Vertical Alignment
• Temperature