ASTM E2764 - 11

    Standard Practice for Uncertainty Assessment in the Context of Seized-Drug Analysis

    Active Standard ASTM E2764 | Developed by Subcommittee: E30.01

    Book of Standards Volume: 14.02

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    Significance and Use

    Application of UncertaintyQualitative and quantitative analyses require different approaches, refer to the references for additional information. Analysts shall understand the limitations of qualitative and quantitative determinations and have tools to estimate a value for measurement uncertainty of relevant, but not necessarily all, numerical results. In this regard, efforts should be made to use the vocabulary, symbols, and formatting expressed in documents published by international standardizing organizations such as ISO and ASTM International.

    An understanding of uncertainty is fundamental to the interpretation and reporting of results.

    The term uncertainty does not imply doubt; rather, its consideration provides assurance that results and conclusions from methods and analytical schemes are fit for purpose.

    The concept of uncertainty shall be considered for both qualitative and quantitative results.

    Laboratory management shall ensure that uncertainty be addressed through the provision of training, procedures and documentation.

    Laboratory management should consider customer requirements, such as a request for qualitative versus quantitative determinations, which influence the assessment of uncertainty.

    The benefits of understanding and determining uncertainty in this context include:

    Enhancing confidence through increased understanding of results,

    Providing a mechanism to express the reliability of results,

    Enabling the laboratory management and customer to evaluate the fitness for purpose of results,

    Facilitating the identification of procedural limitations and providing a basis for improvement, and

    Complying with accreditation requirements.

    1. Scope

    1.1 This practice provides guidance on the concept of uncertainty and its application to the qualitative and quantitative analysis of seized drugs. In this context, uncertainty encompasses limitations of qualitative methods as well as numerical ranges as applied to quantitative analyses.

    1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.3 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 and health practices and determine the applicability of regulatory limitations prior to use.

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E2327 Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis

    E2329 Practice for Identification of Seized Drugs

    E2549 Practice for Validation of Seized-Drug Analytical Methods

    ISO Standards

    ISO 3534-1:1993 Statistics--Part 1: Probability and General Statistical Terms

    ICS Code

    ICS Number Code 11.120.10 (Medicaments)

    UNSPSC Code

    UNSPSC Code

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/E2764-11

    Citation Format

    ASTM E2764-11, Standard Practice for Uncertainty Assessment in the Context of Seized-Drug Analysis, ASTM International, West Conshohocken, PA, 2011,

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