ASTM E2810-19 Standard Practice for Demonstrating Capability to Comply with the Test forUniformity of Dosage Units

Designation: E2810-19 Standard Practice for Demonstrating Capability to Comply with the Test forUniformity of Dosage Units1 1. Scope 1.l This practice provides a general procedure for evaluat-ing the capability to comply with the niformity of DosageUnits (UDUy test. This test is given in General Chapter <905>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 thc 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 prescribedconfidcnce level from a samplc of dosage units. 1.2 This methodology can bc used to gencrate an acceptancelimit table,which defines a set of sample means and standardideviations that assures passing the UDU test for a prescribedlower probability bound,confidence level, and sample size. 1.3 This standard does nor purporr to acldress all of theseafety concerns，if cany. associated wish irs use. It is therespowsibility of the user of this standard to establis appro-pricte scfety,healr. cnd erviroraenral practices and deter-eraive the applicabiliry of re guietory livirations prior to use. 1.4 This inrerncrional siandard was cdeveloped i accor-dance wirh inrernsarioally recognized principles on sandcrd-ization esiablished in the Decisiov on Principles for rheDevelopnenr of Inxterrictional Srandards，Guides and Recoww-mewdcrions issued by the World Trade Organization TechicalBarriers ro Trade (TBTy Cowmaanisee. 2.Referenced Documents 2.1 ASTM Standards:2 E2363 Terminology Relating to Process Analytical Technol-ogy in the Pharmaceutical Industry E2810-19 Standard Practice for Demonstrating Capability to Comply with the Test forUniformity of Dosage Units