ASTM E2810-19 pdf free download.Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of 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 confidcnce 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 hound. confidence level, and sample size.
3. Terminology
3.1 Definitions—See Terminology E2363 for a more extensive listing of terms in ASTM Committee E55 standards.
3.2 Definitions of Terms Specific to This Standard.
3.2. 1 acceptable parameter region, n—the set of values of parameters characterizing the distribution of test results for which the probability of passing the lot acceptance procedure is greater than a prescribed lower bound.
3.2.2 acceptance limit. n—the boundary of the acceptance region, for example. the maximum sample standard deviation for a given sample mean or minimum and maximum sample mean for given standard deviations.
3.2.2.1 Discussion—The coefficient of variation (relative standard deviation) may be substituted for the standard deviation where applicable.
3.2.3 acceptance region, n—the set of values of parameter estimates (that is, sample mean and standard deviation) where confidence limits attain a prescribed lower bound on the probability of passing a lot acceptance procedure.
3.2.4 confidence level, C, n—the prescribed overall level for calculating the uncertainty region of the parameters from the sample estimates.
3.2.4.1 Discussion—The preset confidence level is stated as a percentage, for example, 100 (1 — a) = 95 %, where a is a risk that is allocated to the two parameters being estimated.ASTM E2810 pdf ownload.