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Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus using standard 1 L vessels.
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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 Implementation of this practice requires the use of certified tools or devices with documented traceability.
1.5 Wherever possible, tools shall be traceable to an accepted standard calibration source from a national or international calibration laboratory.
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results.
2.2 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.
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