Standard

ASTM E2810 - 11 en

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

  • This norm is withdrawn since 01-10-2011

50,27 60,83 Incl BTW

About norm

Status Withdrawn
Number of pages 8
Published on 01-10-2011
Language English

1.1 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.

1.2 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.

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.

Details

ICS-code 03.120.30
English title Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
Replaced by

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