1、Designation:E2810112Standard Practice forDemonstrating Capability to Comply with the Test forUniformity of Dosage Units1This standard is issued under the fixed designation E2810;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the yea
2、r of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1NOTEEditorial corrections made throughout in February 2013.2NOTEEditorial corrections made throughout in December 2013.1.Scope1.
3、1 This practice provides a general procedure for evaluat-ing the capability to comply with the Uniformity of DosageUnits(UDU)test.This test is given in General Chapter 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 th
4、e 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 prescribedconfidence level from a sample of dosage units.1.2 This methodology can be used to genera
5、te an acceptancelimit table,which defines a set of sample means and standarddeviations that assures passing the UDU test for a prescribedlower probability bound,confidence level,and sample size.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It
6、is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E2363 Terminology Relating to Process Analytical Technol-ogy in the Pharmaceutical
7、 IndustryE2709 Practice for Demonstrating Capability to Complywith an Acceptance Procedure2.2 Other Documents:JP Japanese Pharmacopoeia3Ph.Eur.European Pharmacopoeia4USP United States Pharmacopeia53.Terminology3.1 DefinitionsSee Terminology E2363 for a more exten-sive listing of terms in ASTM Commit
8、tee E55 standards.3.2 Definitions of Terms Specific to This Standard:3.2.1 acceptable parameter region,nthe set of values ofparameters characterizing the distribution of test results forwhich the probability of passing the lot acceptance procedureis greater than a prescribed lower bound.3.2.2 accept
9、ance limit,nthe boundary of the acceptanceregion,for example,the maximum sample standard deviationfor a given sample mean.3.2.2.1 DiscussionThe coefficient of variation(relativestandard deviation)may be substituted for the standard devia-tion where applicable.3.2.3 acceptance region,nthe set of valu
10、es of parameterestimates(that is,sample mean and standard deviation)whereconfidence limits attain a prescribed lower bound on theprobability of passing a lot acceptance procedure.3.2.4 confidence level,C,nthe prescribed overall level forcalculating the uncertainty region of the parameters from thesa
11、mple estimates.3.2.4.1 DiscussionThe preset confidence level is stated asa percentage,for example,100(1 )=95%,where is arisk that is allocated to the two parameters being estimated.1This practice is under the jurisdiction of ASTM Committee E55 on Manufac-ture of Pharmaceutical and Biopharmaceutical
12、Products and is the direct responsi-bility of Subcommittee E55.03 on General Pharmaceutical Standards.Current edition approved Oct.1,2011.Published December 2011.DOI:10.1520/E2810-11E02.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.
13、org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from the Pharmaceuticals and Medical Devices Agency,Japan,http:/jpdb.nihs.go.jp.4Available from the European Council,Strasbourg,France,http:/www.edqm.eu.5Available from
14、U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.5 lower probability bound,LB,nthe nominal probabil-ity of passing the UDU test for a given set of pa
15、rameterestimates.3.2.6 multiple-stage acceptance procedure,na procedurethat involves more than one stage of sampling and testing agiven quality characteristic with one or more acceptancecriteria per stage.3.2.7 representative sample,na sample that consists of anumber of units that are drawn based on
16、 rational criteria suchas random sampling and intended to assure that the sampleaccurately portrays the material being sampled3.2.8 sampling plan,nscheme for selecting dosage unitsfrom locations within a batch for testing purposes.3.2.8.1 DiscussionIn this standard,a single dosage unit isselected from each batch location.3.2.9 uniformity of dosage units,UDU,nthe degree ofuniformity in the amount of the drug substance among dosageunits.3.2.9.1 DiscussionThe requirements of the UDU test ap-ply to
