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    Marijuana Testing Method Reference Library

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    dsevolve
    This document provides guidance for testing facilities on selecting applicable testing methods for retail and medical marijuana/marijuana products. It outlines reference methods for microbiological contaminants, residual solvents, pesticide residues, and potency determination. However, these reference methods lack full validation for cannabis products and require laboratories to validate methods are fit-for-purpose before implementation. Due to the lack of standard testing methods for cannabis, any methods used must be rigorously validated.

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    © All Rights Reserved
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    Marijuana Testing Method Reference Library

    Uploaded by

    dsevolve
    78 views5 pages
    This document provides guidance for testing facilities on selecting applicable testing methods for retail and medical marijuana/marijuana products. It outlines reference methods for microbiological contaminants, residual solvents, pesticide residues, and potency determination. However, these reference methods lack full validation for cannabis products and require laboratories to validate methods are fit-for-purpose before implementation. Due to the lack of standard testing methods for cannabis, any methods used must be rigorously validated.

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    This document provides guidance for testing facilities on selecting applicable testing methods for retail and medical marijuana/marijuana products. It outlines reference methods for microbiological contaminants, residual solvents, pesticide residues, and potency determination. However, these reference methods lack full validation for cannabis products and require laboratories to validate methods are fit-for-purpose before implementation. Due to the lack of standard testing methods for cannabis, any methods used must be rigorously validated.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    78 views5 pages

    Marijuana Testing Method Reference Library

    Uploaded by

    dsevolve
    This document provides guidance for testing facilities on selecting applicable testing methods for retail and medical marijuana/marijuana products. It outlines reference methods for microbiological contaminants, residual solvents, pesticide residues, and potency determination. However, these reference methods lack full validation for cannabis products and require laboratories to validate methods are fit-for-purpose before implementation. Due to the lack of standard testing methods for cannabis, any methods used must be rigorously validated.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    Reference Methods for the Testing of Retail and Medical

    Marijuana

    Introduction

    Cannabis is a novel industry and, currently, no recognized standard methods exist for
    the testing of cannabis or cannabis products. The purpose of this document is to
    provide guidance to testing facilities on the selection of applicable methodology
    pertaining to the testing of retail and medical marijuana/marijuana products. The
    methods outlined in this library are applicable by comparative use in areas similar to
    the testing of cannabis product; it should not, however, be construed that these
    methods are necessarily fit-for-purpose in all aspects of cannabis testing. The
    references outlined in this document lack complete validation or matrix extension
    specific to cannabis products and thus, require in house laboratory validation prior to
    implementation. Any selected methods must be shown as fit-for-purpose through in-
    house validation. The potency methods referenced for the analysis of
    marijuana/marijuana products are not derived from applicable standard methods as
    no proper standard method is available. Any method employed that was not derived
    from a standard method must be rigorously tested and validated prior to analysis of
    cannabis and cannabis product.

    Note: The sources listed in this document are not exhaustive; other methodologies
    may be appropriate for use. Due to the constant evolution of scientific analytical
    methods, this reference library represents a living document that will be updated as
    needed. Marijuana testing facilities are encouraged to consult with the CDPHE
    certification program during selection and implementation of testing methodologies.

    Microbial Pathogens and Total Yeast and Mold

    Concerning the testing of cannabis product for microbiological contaminants, there is


    a large pool of standard methods on which to draw. All microbiological methods
    employed must include applicable controls. Qualitative pathogen methods must
    confirm presumptive results as either positive or negative by the inclusion of a
    confirmation step. Confirmation of pathogens should not be addressed by simply re-
    running positive sample enrichments or retesting remaining sample.

    8100 Lowry Blvd., Denver, CO 80230-6928 P 303-692-3090 www.colorado.gov/cdphe/lab


    John W. Hickenlooper, Governor | Larry Wolk, MD, MSPH, Executive Director and Chief Medical Officer
    Methods applicable to Salmonella spp. and Shiga toxin-producing Escherichia coli
    testing:

     Association of Analytical Communities (AOAC) 2016. “Salmonella in Foods,


    967.25” http://www.eoma.aoac.org/methods/info.asp?ID=47595
     Food and Drug Administration (FDA), 2016. Bacteriological Analytical Manual
    (BAM).
    http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006
    949.htm
     International Standards Organization (ISO), 2002. “ISO/TS 6579:2002.”
    http://www.iso.org/iso/catalogue_detail.htm?csnumber=29315
     International Standards Organization (ISO), 2012. “ISO/TS 13136:2012.”
    http://www.iso.org/iso/catalogue_detail.htm?csnumber=53328
     Salfinger, Yvonne and Tortorello, Mary Lou, 2015. Compendium of Methods for
    the Microbiological Examination of Foods, 5th Edition. American Public Health
    Association.
     United States Department of Agriculture: Food Safety and Inspection Service
    (USDA FSIS), 2016. Microbiology Laboratory Guidebook.
    http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006
    949.htm

    Methods applicable to total yeast and mold testing:

     Association of Analytical Communities (AOAC) 2016. “Yeast and Mold Counts in


    Foods, 997.02.” http://www.eoma.aoac.org/methods/info.asp?ID=46847
     Food and Drug Administration (FDA), 2016. Bacteriological Analytical Manual
    (BAM).
    http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006
    949.htm
     Salfinger, Yvonne and Tortorello, Mary Lou, 2015. Compendium of Methods for
    the Microbiological Examination of Foods, 5th Edition. American Public Health
    Association.

    Residual Solvent Testing

    Concerning residual solvent testing, there is a large pool of standard methods from
    which to draw. All methods employed must include applicable controls.

    Methods applicable to residual solvent testing:

     American Society for Testing Materials (ASTM), 2016.


    https://global.ihs.com/standards.cfm?publisher=ASTM&RID=Z56&MID=ASTM&gc
    lid=CJTImMLNosoCFQIHaQodhgoHkQ
     Environmental Protection Agency (EPA), 2016. “310B-Residual Solvents.”
    http://www3.epa.gov/ttn/emc/methods/method310b.html
     Lake, Rick., 2016. “RESTEK Revised USP 467 Residual Solvent Method.”
    RESTEK: http://www.restek.com/Technical-Resources/Technical-
    Library/Pharmaceutical/pharm_A017

    8100 Lowry Blvd., Denver, CO 80230-6928 P 303-692-3090 www.colorado.gov/cdphe/lab


    John W. Hickenlooper, Governor | Larry Wolk, MD, MSPH, Executive Director and Chief Medical Officer
     United States Pharmacopeia (USP), 2008. “<467> Residual Solvents.”
    http://www.usp.org/usp-nf/official-text/accelerated-revision-
    process/accelerated-revision-history/general-chapter-organic-volatile

    Pesticide Residue Testing

    Concerning pesticide testing, there is a large pool of standard methods from which to
    draw. All methods employed must include applicable controls.

    Methods applicable to pesticide residue testing:

     Association of Analytical Communities (AOAC) 2016. “Pesticide Residues in


    Foods by Acetonitrile Extraction and Partitioning with Magnesium Sulfate,
    2007.01” http://www.eoma.aoac.org/methods/info.asp?ID=48938
     Collaborative Validation of the QuEChERS Procedure for the Determination of
    Pesticide Residues in Food by LC-MS/MS. J.Agric.Food Chem, 2011,59,6383-
    6411.
     Determination of Pesticide Residues in Foods by Acetonitrile Extraction and
    Partitioning with Magnesium Sulfate: Collaborative Study LEHOTAY: Journal of
    AOAC International Vol.90,No.2,2007.
     Food and Drug Administration (FDA), 2016: Pesticide Analytical Manual (PAM).
    http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006
    955.htm
     International Standards Organization (ISO), 2016.
    http://www.iso.org/iso/home.html
     United States Department of Agriculture: Food Safety and Inspection Service
    (USDA FSIS), 2016. Chemistry Laboratory Guidebook.
    http://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-
    procedures/guidebooks-and-methods/chemistry-laboratory-guidebook

    Potency Determination

    Concerning potency analysis, while several published methods exist, the available
    methods have not been validated to the level of a standard method. The following is a
    list of appropriate reference methods. Potency methods must be validated extensively
    to ensure they meet the requirements of testing.

    Methods applicable to potency determination:

     Backer, Benjamin De., et al., 2009. Innovative development and validation of


    an HPLC/DAD method for the qualitative and quantitative determination of
    major cannabinoids in cannabis plant material. Journal of Chromatography B,
    887 4115-4124.
     Bovens, Michael., et al., 2009. Recommended method for the identification
    and analysis of cannabis and cannabis products: manual for use by National
    drug analysis laboratories. United Nations.
    https://www.unodc.org/documents/scientific/ST-NAR-40-Ebook.pdf

    8100 Lowry Blvd., Denver, CO 80230-6928 P 303-692-3090 www.colorado.gov/cdphe/lab


    John W. Hickenlooper, Governor | Larry Wolk, MD, MSPH, Executive Director and Chief Medical Officer
     Gambaro, Veniero., et al., 2002. Determination of primary active constituents
    in Cannabis preparations by high-resolution gas chromatography/flame
    ionoization detection and high-performance liquid chromatography/UV
    detection. Analytica Chimica Acta 468, 245-254.
     L. Ambach, F. Penitschka, A. Broillet, S. König, W. Weinmann., 2014.
    Simultaneous quantification of delta-9-THC, THC-acid A, CBN and CBD in seized
    drugs using HPLC-DAD. Forensic Science International 243, 107-111.
     Stolker, A.A.M., et al., 2004. Determination of cannabinoids in cannabis
    products using liquid chromatography –ion trap mass spectrometry. Journal of
    Chromatography A, 1058, 143-151.
     Swift, Wendy., et al., 2013. Analysis of Cannabis Seizures in NSW, Australia:
    Cannabis Potency and Cannabinoid Profile, PLOS One v.8 i.7 e70052.
     Upton, Roy., et al., 2014. Cannabis Inflorescence Cannabis Spp.: Standards of
    Identity, Analysis, And Quality Control. American Herbal Pharmacopoeia.

    Validation Guidelines

     Any method derived from a standard method or literature method requires validation
    showing that the method is fit to purpose. In the absence of standard methods, a
    single laboratory validation or equivalent is required to show that the method is fit for
    purpose in the intended matrix and, if applicable, that any modifications to the
    original method do not negatively impact performance. Method validation should, at a
    minimum, verify accuracy, precision, analytical sensitivity, analytical specificity, limit
    of detection, limit of quantification, reportable range and the identification of
    interfering substances. For microbiological methods adopted from a standard method,
    inclusivity/exclusivity does not require complete reassessment, provided that the
    referenced media, primers, probes, antibodies, critical chemistries, etc., were not
    modified.

     Association of Analytical Communities (AOAC) 2012. “Methods Committee


    Guidelines for Validation of Microbiological Methods for Food and
    Environmental Surfaces.” AOAC:
    http://www.aoac.org/imis15_prod/AOAC_Docs/StandardsDevelopment/AOAC_
    Validation_Guidelines_for_Food_Microbiology-Prepub_version.pdf
     Association of Analytical Communities (AOAC) 2002. “Guidelines for Single
    Laboratory Validation of Chemical Methods for Dietary Supplements and
    Botanicals” AOAC:
    http://www.aoac.org/imis15_prod/AOAC_Docs/StandardsDevelopment/SLV_Gu
    idelines_Dietary_Supplements.pdf
     Food and Drug Administration (FDA) 2015. “Analytical Procedures and Methods
    Validation for Drugs and Biologics: Guidance for Industry.” FDA:
    http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformati
    on/guidances/ucm386366.pdf
     Food & Drug Administration Office of Foods and Veterinary Medicine (FDA)
    2015. “Guidelines for the Validation of Analytical Methods for the Detection of
    Microbial Pathogens in Foods and Feeds 2nd Edition.” FDA:

    8100 Lowry Blvd., Denver, CO 80230-6928 P 303-692-3090 www.colorado.gov/cdphe/lab


    John W. Hickenlooper, Governor | Larry Wolk, MD, MSPH, Executive Director and Chief Medical Officer
    http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM298730.pd
    f
     International Conference on Harmonization (ICH) 1996. “Harmonised Tripartite
    Guideline Validation of Analytical Procedures: Text and Methodology.” ICH:
    http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Qua
    lity/Q2_R1/Step4/Q2_R1__Guideline.pdf
     United States Department of Agriculture Food Safety and Inspection Service
    (USDA FSIS) 2010. “Guidance for Test Kit Manufacturers, Laboratories:
    Evaluating the Performance of Pathogen Test Kit Methods.” USDA:
    http://www.fsis.usda.gov/shared/PDF/Validation_Studies_Pathogen_Detection
    _Methods.pdf

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    John W. Hickenlooper, Governor | Larry Wolk, MD, MSPH, Executive Director and Chief Medical Officer

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