ASTM E 2810 : 2011 : EDT 2
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
Hardcopy , PDF
11-11-2014
English
01-10-2011
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 14.05, 2017 Gives a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test.
| Committee |
E 55
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| DocumentType |
Standard Practice
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| Pages |
8
|
| ProductNote |
Reconfirmed EDT 2
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
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 and health practices and determine the applicability of regulatory limitations prior to use.
| ASTM E 2363 : 2014 : REDLINE | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
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