ASTM E2810:19 pdf download

ASTM E2810:2019 pdf download.Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units.
4.3.1 The UDLT test defines a product requirement to be met at release and throughout the shelf-uk of the product.
4.3.2 Passing the UDU lest once does not provide statistical assurance that a hatch of drug product meets specified statistical quality control criteria.
4.4 This practice provides a practical specihcation that may be applied when uniformity of dosage units is required. An acceptance region for the mean and standard deviation of a set of test results from the lot is defined such that. at a prescribed confidence level, the probability that a future sample from the lot will pass the LJDU test is greater than or equal to a prespeci fled lower probability bound. Ilaving test results fall in the acceptance region provides assurance that a sample would pass the UDLJ test with at least the specified lower bound probability. This procedure does not account for any decrease in potency during the shelf life, which could atTect the ability to meet the UDIJ test requirements.
4.5 This practice can be used as an clement for process demonstration or validation. continuous process ventication, in-process testing. or lot release (acceptance). As the circuinstances and available infi,rmation vary in these difl’erent application areas, this practice does not prescribe a specific target. sample size, lower probability bound, or confidence level. These must be prospectively selected by the user and may be ditkrent from those used in the acceptance limit tables provided in this practice.
5. Procedure
5. 1 .1 The general procedure that generates the acceptance limit tables is described in Practice E27 test is described in the literature (4). A simplified description on the construction anduse of these tables is given in this section.A computer programis required to generate the tables given a target T as apercentage of label claim (LC), a lower probability bound LB,a confidence level C, and a sample size n.
5.1.2 The first step is to determine the acceptable parameterregion. On a two-dimensional content space consisting of thetrue mean (u) on the horizontal axis and standard deviation (o)on the vertical axis the upper 95 % LB boundary of this regionis defined by a contour, a curve that is concave downward anddepicted by the solid curve in Fig. 1.The simulated 95%boundary for the actual probability of passing the USP UDUtest is defined by the dashed contour that shows the effect ofgenerating a lower bound.The LB contour is determined by theLB probability (95 %) and the target under the assumption thatthe dosage unit content is normally distributed.The acceptableparameter region is the set of points on or below the contour.Any (u, a) pair in the acceptable region would pass the UDUtest with a probability of at least the LB.