Significance and Use
This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results.
Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required.
Scope
1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus.
1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is, a valve in the bottom of the vessel or sampling through the shaft).
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
