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ASTM E2810 PDF
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Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
| Published by | Publication Date | Number of Pages |
| ASTM | 04/01/2019 | 20 |
ASTM E2810 – Standard Practice forDemonstrating Capability to Comply with the Test for Uniformityof Dosage Units
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.
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