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ASTM E2810-2011e1 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

Standard Number:  ASTM E2810-2011e1
Title:  Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
Language:  English
Replaced by Standard:  ASTM E2810-11e2

Replacing Standard:  ASTM E2810-11

Status:  Withdrawn
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Pharmaceutics>>Other standards related to pharmaceutics
Publisher:  American Society for Testing Material (ASTM)
Price:  
Number of Pages:  

Description:

Scope

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.

  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  655KB
Tile in English:  Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

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