Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
|Publication Date:||1 April 2019|
|ICS Code (Other standards related to pharmaceutics):||11.120.99|
|ICS Code (Application of statistical methods):||03.120.30|
This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test. This test is given in General Chapter <905> Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates made at a prescribed confidence level from a sample of dosage units.
This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size.
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.
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.