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ASTM E2329-09

(Practice)

Standard Practice for Identification of Seized Drugs

Standard Practice for Identification of Seized Drugs

SIGNIFICANCE AND USE
These are minimum standards applicable to the identification of seized drugs.
It is recognized that the correct identification of a drug or chemical depends on the use of an analytical scheme based on validated methods and the competence of the analyst.
This practice requires the use of multiple uncorrelated techniques. It does not discourage the use of any particular method within an analytical scheme. Unique requirements in different jurisdictions may dictate the actual practices followed by a particular laboratory.
These are minimum standards for identification of commonly seized drugs. However, it should be noted that they may not be sufficient for identification of all drugs in all circumstances. Within this practice, it is up to the individual laboratory to determine which combination of analytical techniques best satisfies the requirements of its jurisdictions.
SCOPE
1.1 This practice describes minimum criteria for the qualitative analysis (identification) of seized drugs.
1.2 Listed are a number of analytical techniques for the identification of seized drugs. These techniques are grouped on the basis of their discriminating power. Analytical schemes based on these groupings are described.
1.3 Additional information is found in Guides E1968 and E1969and Practices E2326  and E2327.

General Information

Status
Historical
Publication Date
31-May-2009
ICS
11.120.10 - Medicaments
Technical Committee
E30 - Forensic Sciences
Drafting Committee
E30.01 - Criminalistics
Current Stage
Ref Project

Relations

Replaces
ASTM E2329-04 - Standard Practice for Identification of Seized Drugs
Effective Date
01-Jun-2009
Replaced By
ASTM E2329-10 - Standard Practice for Identification of Seized Drugs
Effective Date
15-Dec-2010
Referred By
ASTM E1968-19 - Standard Practice for Microcrystal Testing in Forensic Analysis for Cocaine
Effective Date
01-Jun-2009
Referred By
ASTM E2882-19 - Standard Guide for Analysis of Clandestine Drug Laboratory Evidence
Effective Date
01-Jun-2009
Referred By
ASTM E2327-15e1 - Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis
Effective Date
01-Jun-2009
Referred By
ASTM E2548-16 - Standard Guide for Sampling Seized Drugs for Qualitative and Quantitative Analysis
Effective Date
01-Jun-2009
Referred By
ASTM E1969-19 - Standard Practice for Microcrystal Testing in Forensic Analysis for Methamphetamine and Amphetamine
Effective Date
01-Jun-2009
Referred By
ASTM E2125-19 - Standard Practice for Microcrystal Testing in Forensic Analysis for Phencyclidine and Its Analogues
Effective Date
01-Jun-2009

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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2329 – 09
Standard Practice for
1
Identification of Seized Drugs
This standard is issued under the fixed designation E2329; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope different jurisdictions may dictate the actual practices followed
by a particular laboratory.
1.1 This practice describes minimum criteria for the quali-
3.4 These are minimum standards for identification of
tative analysis (identification) of seized drugs.
commonly seized drugs. However, it should be noted that they
1.2 Listed are a number of analytical techniques for the
may not be sufficient for identification of all drugs in all
identification of seized drugs.These techniques are grouped on
circumstances. Within this practice, it is up to the individual
the basis of their discriminating power. Analytical schemes
laboratory to determine which combination of analytical tech-
based on these groupings are described.
niques best satisfies the requirements of its jurisdictions.
1.3 Additional information is found in Guides E1968 and
E1969 and Practices E2326 and E2327.
4. Categories of Analytical Techniques
2. Referenced Documents 4.1 For the purpose of this practice, techniques for the
2
analysis of drug samples may be divided into three categories
2.1 ASTM Standards:
based on their discriminating power. Table 1 provides ex-
E1968 Guide for Microcrystal Testing in the Forensic
,
amples of techniques in order of decreasing discriminating
Analysis of Cocaine
power, from A to C.
E1969 Guide for Microcrystal Testing in the Forensic
,
Analysis of Methamphetamine and Amphetamine
5. Identification Criteria
E2326 Practice for Education and Training of Seized-Drug
5.1 This practice requires that the following minimum
Analysts
criteria be followed when making analytical identifications
E2327 Practice for Quality Assurance of Laboratories Per-
5.1.1 When a validated Category A technique is incorpo-
forming Seized-Drug Analysis
rated into an analytical scheme, then at least one other
2.2 Other Document:
technique (from either Category A, B or C) must be used.
Scientific Working Group for the Analysis of Seized Drugs
5.1.1.1 This combination must identify the specific drug
Recommendations for: Education and Training, Quality
present and must preclude a false positive identification.
Assurance, Methods of Analysis
5.1.1.2 When sample size allows, the second technique
3. Significance and Use should be applied on a separate sampling for quality assurance
reasons. When sample size is limited, additional measures
3.1 These are minimum standards applicable to the identi-
should be taken to assure that the results correspond to the
fication of seized drugs.
correct sample.
3.2 It is recognized that the correct identification of a drug
5.1.1.3 All Category A techniques must have data that are
or chemical depends on the use of an analytical scheme based
reviewable.
on validated methods and the competence of the analyst.
5.1.2 When a CategoryAtechnique is not used, then at least
3.3 This practice requires the use of multiple uncorrelated
three different validated methods must be employed.
techniques. It does not discourage the use of any particular
5.1.2.1 These in combination must demonstrate the identity
method within an analytical scheme. Unique requirements in
of the specific drug present and must preclude a false positive
identification.
5.1.2.2 Two of the three methods must be based on uncor-
1
This practice is under the jurisdiction of ASTM Committee E30 on Forensic
related techniques from Category B.
Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.
5.1.2.3 A minimum of two separate samplings should be
CurrenteditionapprovedJune1,2009.PublishedJuly2009.Originallyapproved
used in these three tests. When sample size is limited, addi-
in 2004. Last previous edition approved in 2004 as E2329 – 04. DOI: 10.1520/
E2329-09.
tional measures should be taken to assure that the results
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
correspond to the correct sample.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
5.1.2.4 All Category B techniques must have reviewable
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. data.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E2329 – 09
TABLE 1 Categories of Analytical Techniques
Category A Category B Category C
Infrared Spectroscopy Capillary Elec
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:E2329–04 Designation: E 2329 – 09
Standard Practice for
1
Identification of Seized Drugs
This standard is issued under the fixed designation E 2329; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice describes minimum criteria for the qualitative analysis (identification) of seized drugs.
1.2 Listed are a number of analytical techniques for the identification of seized drugs.These techniques are grouped on the basis
of their discriminating power. Analytical schemes based on these groupings are described.
1.3 Additional information is found in Guides E1968 and E1969and Practices E2326 and E2327.
2. Referenced Documents
2
2.1 ASTM Standards:
E1968
E 1968 Guide for Microcrystal Testing in the Forensic Analysis of Cocaine
E1969
E 1969 Guide for Microcrystal Testing in the Forensic Analysis of Methamphetamine and Amphetamine
E 2326 Practice for the Education and Training of Seized-Drug Analysts
E 2327 Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis
2.2 Other Document:
Scientific Working Group for the Analysis of Seized Drugs Recommendations for: Education and Training, Quality Assurance,
Methods of Analysis
3. Significance and Use
3.1 These are minimum standards applicable to the identification of seized drugs.
3.2 It is recognized that the correct identification of a drug or chemical depends on the use of an analytical scheme based on
validated methods and the competence of the analyst.
3.3 This practice requires the use of multiple uncorrelated techniques. It does not discourage the use of any particular method
withinananalyticalscheme.Uniquerequirementsindifferentjurisdictionsmaydictatetheactualpracticesfollowedbyaparticular
laboratory.
3.4 These are minimum standards for identification of commonly seized drugs. However, it should be noted that they may not
besufficientforidentificationofalldrugsinallcircumstances.Withinthispractice,itisuptotheindividuallaboratorytodetermine
which combination of analytical techniques best satisfies the requirements of its jurisdictions.
4. Categories of Analytical Techniques
4.1 For the purpose of this practice, techniques for the analysis of drug samples may be divided into three categories based on
their discriminating power. Table 1 provides examples of techniques in order of decreasing discriminating power, from A to C.
5. Identification Criteria
5.1 This practice requires that the following minimum criteria be followed when making analytical identifications
5.1.1 When a validated CategoryAtechnique is incorporated into an analytical scheme, then at least one other technique (from
either Category A, B or C) must be used.
5.1.1.1 This combination must identify the specific drug present and must preclude a false positive identification.
5.1.1.2 When sample size allows, the second technique should be applied on a separate sampling for quality assurance reasons.
When sample size is limited, additional measures should be taken to assure that the results correspond to the correct sample.
1
This practice is under the jurisdiction of ASTM Committee E30 on Forensic Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics .
Current edition approved Aug. 1, 2004. Published September 2004.
Current edition approved June 1, 2009. Published July 2009. Originally approved in 2004. Last previous edition approved in 2004 as E 2329–04.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. ForAnnualBookofASTMStandards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E2329–09
TABLE 1 Categories of Analytical Techniques
Category A Category B Category C
Infrared Spectroscopy Capillary Electrophoresis Color Tests
Mass Spectrometry Gas Chromatography Fluorescence Spectroscopy
Nuclear Magnetic Ion Mobility Spectrometry Immunoassay
Resonance Spectroscopy
Raman Spectroscopy Liquid Chromatography Melting Point
Microcrystalline Tests Ultraviolet Spectroscopy
Pharmaceutical Identifiers
Thin Layer
Chromatography
Cannabis only:
Macroscopic Examination
Microscopic Exam
...

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SCOPE
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SCOPE
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SCOPE
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4.4 This guide supports, and is consistent with, elements of the European Commission (EU) Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (27, 28) and guidance from the International Society of Pharmaceutical Engineers (ISPE) (29) in which it is mentioned that relevant residue limits should be based on a toxicological evaluation.  
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SCOPE
1.1 This guide describes the scientific procedures underlying the integrative interpretation of all data concerning an active pharmaceutical ingredient (API) taking into account study adequacy, relevance, reliability, validity, and compound-specific characteristics (for example, potency, toxicological profile, and pharmacokinetics) leading to a numerical value for the API, which is used further in the quality risk management (ICH Q9) of cross contamination during the manufacture of different products in the same manufacturing facilities.  
1.2 This guide describes general guidance for calculating and documenting a health-based exposure limit (HBEL). It should serve the involved qualified experts as a reference for HBEL derivations and should harmonize the different approaches and nomenclature to the greatest extent possible.  
1.3 This guide should be used for calculating and documenting an HBEL, when required or necessary, for APIs (including biologics), intermediates, cleaning agents, excipients, and other chemicals (that is, reagents, manufacturing residues, and so forth) used for cleaning validation and verification (Guides F3127 and E3106). In scope is the cleaning and cross contamination of surfaces of manufacturing equipment and medical devices but does not include leachables/extractables (21 CFR 211.67, 21 CFR 610.11, 21 CFR 820.70, and 21 CFR 111.27).  
1.4 The principles in this guide may also be used as a basis for setting occupational exposure limits.  
1.5 The principles in this guide may be applied during the development and commercial manufacturing of small or large molecular weight medicines as well as isolated pharmaceutical intermediates.  
1.6 Subsequent-product HBEL values may be set for specific routes of exposure (for example, oral, inhalation, and parenteral) when necessary (for example, because of differences in bioavailability) and for specific patient populations (for example, children) if ...

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ASTM
ASTM F2602-18(Test Method)
Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)

SIGNIFICANCE AND USE
4.1 The degree of deacetylation of chitosan, as well at the molar mass and molar mass distribution, determines the functionality of chitosan in an application. For instance, functional and biological effects are highly dependent upon the composition and molar mass of the polymer.  
4.2 This test method describes procedures for measurement of molar mass of chitosan chlorides and glutamates, and chitosan base, although it in principle applies to any chitosan salt. The measured molar mass is that for chitosan acetate, since the mobile phase contains acetate as counter ion. This value can further be converted into the corresponding molar mass for the chitosan as a base, or the parent salt form (chloride or glutamate).  
4.3 Light scattering is one of very few methods available for the determination of absolute molar mass and structure, and it is applicable over the broadest range of molar masses of any method. Combining light scattering detection with size exclusion chromatography (SEC), which sorts molecules according to size, gives the ability to analyze polydisperse samples, as well as obtaining information on branching and molecular conformation. This means that both the number-average and mass-average values for molar mass and size may be obtained for most samples. Furthermore, one has the ability to calculate the distributions of the molar masses and sizes.  
4.4 Multi-angle laser light scattering (MALS) is a technique where measurements of scattered light are made simultaneously over a range of different angles. MALS detection can be used to obtain information on molecular size, since this parameter is determined by the angular variation of the scattered light. Molar mass may in principle be determined by detecting scattered light at a single low angle (LALLS). However, advantages with MALS as compared to LALLS are: (1) less noise at larger angles, (2) precision of measurements is improved by detecting at several angles, and (3) the ability to detect angular v...
SCOPE
1.1 This test method covers the determination of the molar mass of chitosan and chitosan salts intended for use in biomedical and pharmaceutical applications as well as in tissue engineered medical products (TEMPs) by size exclusion chromatography with multi-angle laser light scattering detection (SEC-MALS). A guide for the characterization of chitosan salts has been published as Guide F2103.  
1.2 Chitosan and chitosan salts used in TEMPs should be well characterized, including the molar mass and polydispersity (molar mass distribution) in order to ensure uniformity and correct functionality in the final product. This test method will assist end users in choosing the correct chitosan for their particular application. Chitosan may have utility as a scaffold or matrix material for TEMPs, in cell and tissue encapsulation applications, and in drug delivery formulations.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM E2329-17(Practice)
Standard Practice for Identification of Seized Drugs

SIGNIFICANCE AND USE
4.1 These are minimum requirements applicable to the identification of seized drugs.  
4.1.1 As these are minimum requirements, it should be recognized that they may not be sufficient for the identification of all drugs in all circumstances. Within these requirements, it is the responsibility of the individual laboratory’s management to determine which combination of analytical techniques best satisfies the requirements of its jurisdiction.4  
4.2 Correct identification of a drug or chemical depends on the competence of the analyst and the use of an analytical scheme that incorporates validated methods (see Practice E2549). It is expected that in the absence of unforeseen error, an appropriate analytical scheme effectively results in reliable and scientifically supported identifications5 (see Practice E2764).  
4.3 This practice requires the laboratory’s analytical scheme to incorporate techniques that operate on significantly different principles. It does not discourage the use of any particular method within an analytical scheme. Actual practices followed by a particular laboratory may depend upon jurisdictional requirements.
SCOPE
1.1 This practice describes minimum criteria for the qualitative analysis (identification) of seized drugs.  
1.2 Listed are a number of analytical techniques for the identification of seized drugs. These techniques are grouped on the basis of their discriminating power. Analytical schemes based 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 standard should be used in conjunction with sound professional judgment, and cannot replace knowledge, skill, or ability acquired through appropriate education, training, and experience.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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