ASTM E2810-11(2017) Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units.pdf
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1、Designation: E2810 11 (Reapproved 2017)Standard 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 cas
2、e of revision, the year 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.1. Scope1.1 This practice provides a general procedure for evaluat-ing the capability to comply with th
3、e 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 the JP, and these versions are virtuallyinterchangeable. For this multiple-stage test, th
4、e 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 generate an acceptancelimit table, which defines a set of sample means and standarddeviat
5、ions 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 is theresponsibility of the user of this standard to establish appro-priate s
6、afety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment
7、of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E2363 Terminology Relating to Process Analytical Technol-ogy in the Pharmaceutical IndustryE2709 Practice for Demonstra
8、ting 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 Committee E55 standards.3.2 Definitions
9、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 acceptance limit, nthe boundary of the
10、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 values of parameterestimates (t
11、hat 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 thesample estimates.3.2.4.1
12、 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.3.2.5 lower probability bound, LB, nthe nominal probabil-ity of passing the UDU test for a given set of parameterestimates.1This pract
13、ice is under the jurisdiction of ASTM Committee E55 on Manufac-ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi-bility of Subcommittee E55.03 on General Pharmaceutical Standards.Current edition approved Oct. 1, 2017. Published October 2017. Originallyapproved in 2011.
14、 Last previous edition approved in 2011 as E2810 112. DOI:10.1520/E2810-11R17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page on
15、the ASTM website.3Available from the Pharmaceuticals and Medical Devices Agency (PMDA),Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013,Japan, https:/www.pmda.go.jp.4Available from the European Directorate for the Quality of Medicines andHealth Care (EDQM), Council of Europ
16、e, 7 alle Kastner, CS 30026, F-67081Strasbourg, France, http:/www.edqm.eu.5Available from U.S. Pharmacopeial Convention (USP), 12601 TwinbrookPkwy., Rockville, MD 20852-1790, http:/www.usp.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United
17、StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to
18、 Trade (TBT) Committee.13.2.6 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
19、 based on 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 is
20、selected 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 each drug substance in dosage units containing one ormore drug substances, unless other
21、wise specified. The unifor-mity improves as the variability decreases.4. Significance and Use4.1 The methodology was originally developed (1-4)6foruse in drug content uniformity and dissolution but has generalapplication to any multistage test with multiple acceptancecriteria. Practice E2709 summari
22、zes the statistical aspects ofthis methodology. This practice applies the general methodol-ogy of Practice E2709 specifically to the UDU test.4.1.1 While other methods can be used to estimate theprobability of passing the UDU test, they are outside the scopeof this practice.4.2 The UDU test procedur
23、e describes a two-stage samplingtest, where at each stage one can pass or continue testing, andthe decision to fail is deferred until the second stage. At eachstage there are acceptance criteria on the test results as outlinedin Table 1.4.3 The UDU test is a market standard. The USP GeneralNotices i
24、nclude the following statement about compendialstandards. “The similarity to statistical procedures may seem tosuggest an intent to make inference to some larger group ofunits, but in all cases, statements about whether the compendialstandard is met apply only to the units tested.” Therefore, theUDU
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