ASTM E2810-11e2
Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

Standard No.

ASTM E2810-11e2

Release Date

2011

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM E2810-11(2017)

Latest

ASTM E2810-23

Scope

4.1 The methodology was originally developed (1-4)⁶ for use in drug content uniformity and dissolution but has general application to any multistage test with multiple acceptance criteria. Practice E2709 summarizes the statistical aspects of this methodology. This practice applies the general methodology of Practice E2709 specifically to the UDU test.

4.1.1 While other methods can be used to estimate the probability of passing the UDU test, they are outside the scope of this practice.

4.2 The UDU test procedure describes a two-stage sampling test, where at each stage one can pass or continue testing, and the decision to fail is deferred until the second stage. At each stage there are acceptance criteria on the test results as outlined in Table 1.

TABLE 1 Uniformity of Dosage Units Test Procedure

Note 1—All measurements of dosage units and criteria values are in percentage label claim (%LC). At each stage calculate the sample average, X, and the sample standard deviation, s.

Stage	Number Tested	Pass Stage If:
S1	10	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 Chapter8201;lt;905gt; 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 Dosag...... ASTM E2810-11e2 Referenced Document ASTM E2363 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry ASTM E2709 Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure ASTM E2810-11e2 history 2023 ASTM E2810-23 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units 2019 ASTM E2810-19 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units 2017 ASTM E2810-11(2017) Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units 2011 ASTM E2810-11e2 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units 2011 ASTM E2810-11e1 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units 2011 ASTM E2810-11 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units Copyright ©2024 All Rights Reserved