ASTM E2329-2017 Standard Practice for Identification of Seized Drugs《扣押毒品鉴定的标准实践规程》.pdf

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1、Designation: E2329 17Standard Practice forIdentification of Seized Drugs1This standard is issued under the fixed designation E2329; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses

2、indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice describes minimum criteria for the quali-tative analysis (identification) of seized drugs.1.2 Listed are a number of analytical techniques for

3、theidentification of seized drugs. These techniques are grouped onthe basis of their discriminating power. Analytical schemesbased on these groupings are described.1.3 Additional information is found in Guides E1968,E1969, E2125, and E2548 and Practices E2326, E2327, E2549,and E2764.1.4 This standar

4、d should be used in conjunction with soundprofessional judgment, and cannot replace knowledge, skill, orability acquired through appropriate education, training, andexperience.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsib

5、ility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization

6、 established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E1968 Guide for Microcrystal Testing in Forensic Analysis

7、of CocaineE1969 Guide for Microcrystal Testing in Forensic Analysisof Methamphetamine and AmphetamineE2125 Guide for Microcrystal Testing in Forensic Analysisof Phencyclidine and Its AnaloguesE2326 Practice for Education and Training of Seized-DrugAnalystsE2327 Practice for Quality Assurance of Labo

8、ratories Per-forming Seized-Drug AnalysisE2548 Guide for Sampling Seized Drugs for Qualitative andQuantitative AnalysisE2549 Practice for Validation of Seized-Drug AnalyticalMethodsE2764 Practice for UncertaintyAssessment in the Context ofSeized-Drug Analysis2.2 Other Document:SWGDRUG Scientific Wor

9、king Group for the Analysis ofSeized DrugsRecommendations for: Education andTraining, Quality Assurance, Methods of Analysis33. Terminology3.1 DefinitionsTerms that may assist in interpreting thispractice are found in the SWGDRUG Glossary of Terms andDefinitions, Annex A.34. Significance and Use4.1

10、These are minimum requirements applicable to theidentification of seized drugs.4.1.1 As these are minimum requirements, it should berecognized that they may not be sufficient for the identificationof all drugs in all circumstances. Within these requirements, itis the responsibility of the individual

11、 laboratorys managementto determine which combination of analytical techniques bestsatisfies the requirements of its jurisdiction.44.2 Correct identification of a drug or chemical depends onthe competence of the analyst and the use of an analyticalscheme that incorporates validated methods (see Prac

12、ticeE2549). It is expected that in the absence of unforeseen error,an appropriate analytical scheme effectively results in reliableand scientifically supported identifications5(see PracticeE2764).1This practice is under the jurisdiction of ASTM Committee E30 on ForensicSciences and is the direct res

13、ponsibility of Subcommittee E30.01 on Criminalistics.Current edition approved Oct. 1, 2017. Published October 2017. Originallyapproved in 2004. Last previous edition approved in 2014 as E2329 14. DOI:10.1520/E2329-17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact AST

14、M Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from the Scientific Working Group for the Analysis of Seized Drugs(SWGDRUG), http:/www.swgdrug.org/approved.htm.4EURACHEM, The Fitnes

15、s for Purpose of Analytical Methods A LaboratoryGuide to Method Validation and Related Topics, 2nd ed., 2014.5Milman, B. L., Chemical Identification and Its Quality Assurance, Springer-Verlag, 2011.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. Un

16、ited 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 Barrie

17、rs to Trade (TBT) Committee.14.3 This practice requires the laboratorys analytical schemeto incorporate techniques that operate on significantly differentprinciples. It does not discourage the use of any particularmethod within an analytical scheme. Actual practices followedby a particular laborator

18、y may depend upon jurisdictionalrequirements.5. Categories of Analytical Techniques5.1 For the purpose of this practice, techniques for theanalysis of drug samples are classified into three categories(see Table 1) based on their maximum potential discriminatingpower. However, the classification of a

19、 technique may belower, if the sample, analyte, or mode of operation diminishesits discriminating power.5.1.1 Examples of diminished discriminating power includebut are not limited to:5.1.1.1 An infrared spectroscopy technique applied to amixture which produces a combined spectrum, and5.1.1.2 A mass

20、 spectrometry technique (low or high resolu-tion) which only produces molecular weight information.6. Identification Criteria6.1 This practice requires that the following minimumcriteria be utilized when making analytical identifications:6.1.1 When a Category A technique is incorporated into ananaly

21、tical scheme, at least one other technique (from eitherCategory A, B, or C) shall be used.6.1.2 When a Category A technique is not used, at leastthree different techniques shall be employed. Two of the threetechniques shall be from Category B.6.1.2.1 For cannabis, macroscopical and microscopical ex-

22、aminations will be considered as different techniques fromCategory B when observations include documented details ofbotanical features. Laboratories shall define the acceptancecriteria for these features for each examination.6.1.2.2 For exhibits of cannabis that lack sufficient observ-able macroscop

23、ic and microscopic botanical detail (forexample, extracts or residues), 9-tetrahydrocannabinol (THC)or other cannabinoids shall be identified utilizing the principlesset forth in 6.1.1 and 6.1.2.6.1.3 Identification of botanical material may alternativelybe made utilizing morphological characteristi

24、cs (Category B)alone provided sufficient botanical features appropriate foridentification are observed. Such examinations shall only bemade by analysts competent in botanical identifications. In thiscontext, botanical competence exclusively applies to thoseexaminers recognized as professional botani

25、sts or those as-sessed to be competent by such. Identifications of chemicalcomponents contained in botanicals (mescaline, opiates,psilocin, etc.) should rely on principles of chemical identifica-tion set forth in 6.1.1 and 6.1.2.6.1.4 All Category Aand botanical identifications shall havedata that a

26、re reviewable. Where a Category A technique is notused, the requirement for reviewable data applies to Cat-egory B techniques. Examples of reviewable data are:6.1.4.1 Spectra, chromatograms and photographs, and digi-tal images or photocopies (color where appropriate) of thinlayer chromatography (TLC

27、) plates;6.1.4.2 Contemporaneous documented peer review, photo-graphs or digital images, for microcrystalline tests;6.1.4.3 Recording of detailed descriptions or digital imagesof morphological characteristics for cannabis and botanicalmaterials (only); and6.1.4.4 Reference to published data for phar

28、maceuticalidentifiers.6.1.5 For the use of any method to be considered of value,test results shall corroborate each other and shall be considered“positive” (for instance, it must meet the acceptance criteriadefined in the method validation operating protocol). Whenpossible, data from a test result s

29、hall be compared to datagenerated from a reference material which has been analyzedunder the same analytical conditions (see Practice E2327).While “negative” test results provide useful information forruling out the presence of a particular drug or drug class, theseresults have little value toward e

30、stablishing the forensic iden-tification of a drug.6.1.6 The laboratory shall employ quality assurance mea-sures to ensure the results correspond to the exhibit. Examplesof quality assurance measures are:6.1.6.1 The analysis of two or more separate portions,6.1.6.2 Sample identification procedures s

31、uch as bar-codingand witness checks, and6.1.6.3 Good laboratory practices (for example, positive andnegative controls, one sample opened at a time, proceduralblanks).6.1.7 In cases where hyphenated techniques are used (forexample, gas chromatography-mass spectrometry, liquidchromatography-diode arra

32、y ultraviolet spectrophotometry),they will be considered as separate techniques provided thattheir individual acceptance criteria are fulfilled and the resultsfrom each are used.6.1.8 The chosen analytical scheme shall demonstrate theidentity of the specific drug(s) present and shall minimize falsep

33、ositive and false negative identification. Where a scheme haslimitations, this shall be reflected in the reported result (seePractice E2764).TABLE 1 Categories of Analytical TechniquesCategory A Category B Category CInfrared Spectroscopy Capillary Electrophoresis Color TestsMass Spectrometry Gas Chr

34、omatography FluorescenceSpectroscopyNuclear MagneticResonanceSpectroscopyIon Mobility Spectrometry ImmunoassayRaman Spectroscopy Liquid Chromatography Melting PointX-Ray Diffractometry Microcrystalline Tests Ultraviolet SpectroscopyPharmaceutical IdentifiersThin LayerChromatographySupercritical Flui

35、dChromatographyCannabis Only:MacroscopicalExaminationMicroscopicalExaminationE2329 1727. Keywords7.1 identification; qualitative analysis; seized drugsASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Use

36、rs of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every

37、 five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technic

38、al committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken

39、, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 173