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ASTM E2810-2011 standard practice for demonstrating capability to comply with the test for uniformity of dosage units

Standard Number:  ASTM E2810-2011
Title:  standard practice for demonstrating capability to comply with the test for uniformity of dosage units
Language:  English
Replaced by Standard:  ASTM E2810-2011e1

Publication Date:  2011/10/1
Execute Date:  2011/10/1
Status:  Withdrawn
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Pharmaceutics>>Other standards related to pharmaceutics
CCS Classification for Standardscomprehensive>>measurement>>Quantity and unit
Publisher:  American Society for Testing Material (ASTM)
Price:  
Number of Pages:  

Description:1.1 this practice provides a general procedure for evaluatingthe capability to comply with the uniformity of dosageunits (udu) test. this test is given in general chapter uniformity of dosage units of the usp, in 2.9.40 uniformityof dosage units of the ph. eur., and in 6.02 uniformity ofdosage units of the jp, and these versions are virtuallyinterchangeable. for this multiple-stage test, the procedurecomputes a lower bound on the probability of passing the udutest, based on statistical estimates made at a prescribedconfidence level from a sample of dosage units.1.2 this methodology can be used to generate an acceptancelimit table, which defines a set of sample means and standarddeviations that assures passing the udu test for a prescribedlower probability bound, confidence level, and sample size.1.3 this standard does not purport to address all of thesafety concerns, if any, associated with its use. it is theresponsibility of the user of this standard to establish appropriatesafety and health practices and determine the applicabilityof regulatory limitations prior to use.  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  170KB
Tile in English:  standard practice for demonstrating capability to comply with the test for uniformity of dosage units

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