ASTM E2810-11
Historical Standard: ASTM E2810-11 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
SUPERSEDED (see Active link, below)
ASTM E2810
1. 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.
1.2 This 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.
1.3 This 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
E2709 Practice for Demonstrating Capability to Comply with an Acceptance Procedure
Other Documents
USP United States Pharmacopeia Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.Keywords
acceptance limits; acceptance sampling inspection; multiple-stage sampling test; uniformity of dosage units;
ICS Code
ICS Number Code 03.120.30 (Application of statistical methods); 11.120.99 (Other standards related to pharmaceutics)
DOI: 10.1520/E2810-11
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