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ASTM E2810-19
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Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
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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.
| Author | ASTM |
|---|---|
| Editor | ASTM |
| Document type | Standard |
| Format | File |
| ICS | 03.120.30 : Application of statistical methods
11.120.99 : Other standards related to pharmaceutics |
| Number of pages | 20 |
| Replace | ASTM E2810-11(2017) |
| Year | 2019 |
| Document history | ASTM E2810-11(2017) ASTM E2810-11e2 ASTM E2810-11e1 ASTM E2810-11 |
| Country | USA |
| Keyword | ASTM 2810;ASTM E2810;ASTM E2810;10.1520/E2810-19 |