ASTM E 2810 : 2019

Name: ASTM E 2810 : 2019
Brand: ASTM
Price: 83.00 USD

Superseded

View Superseded by

Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

Available format(s)

Hardcopy , PDF

Superseded date

12-23-2023

Language(s)

English

Published date

08-10-2023

Publisher

American Society for Testing and Materials

This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test.

1.1This 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.

1.2This 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.

1.3This 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.

1.4This 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.

Committee	E 55
DocumentType	Standard Practice
Pages	20
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM E 2810 : 2023
Supersedes	ASTM E 2810 : 2011 : R2017

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ASTM E 2363 : 2014	Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry