D37.03 - Laboratory

SIGNIFICANCE AND USE
5.1 The analysis and reporting of cannabinoid content in cannabis and hemp is required to address human health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions. This test method is useful in providing quantitative results for up to seventeen cannabinoids in dried cannabis and hemp raw material samples.
SCOPE
1.1 This test method allows for the concentration determination of the cannabinoids listed in Table 1, and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived.2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those that can be classified as hemp. The procedure includes sub-sampling a ground, homogeneous sample, extraction with methanol:water (80:20, v:v),3,4 dilution in methanol and analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). The method allows for a wide-range of sample concentrations to be determined by using a 1000-fold calibration range and the option to perform multiple levels of sample dilution. The calibration curve is prepared in methanol over a range of 10 ng/mL to 10 000 ng/mL for all seventeen cannabinoids, or a subset of cannabinoids if desired, while the sample extracts are diluted in methanol into the calibration range.3,4,5 For example, a 1/500 dilution of sample extracts allows concentration determination over a range of 0.5 mg/g to 500 mg/g in cannabis. The method was validated with quality control samples prepared in methanol, a candidate certified reference material (CRM), and repeat extraction and analysis of cannabinoid samples.3  
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 List of Measurable Analytes—See Table 1.  
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.

SIGNIFICANCE AND USE
5.1 The analysis and reporting of pesticide content in all forms of cannabis raw material that is grown or processed or both, with the intent of ingestion or consumption, is required to address health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions where cannabis has been legalized for ingestion or consumption for medicinal or recreational purposes, or both. This test method is useful in providing quantitative results for the analytes listed in Table 1, which is a subset of the pesticide testing requirements found in regulatory documents for cannabis, not limited to and including Canada, many U.S. states where legalization has occurred, and the European Pharmacopeia (1-4). This test method may be appropriate for additional pesticide and growth regulator analytes, which may be added to those of Table 1 provided validation is performed in accordance with Practice D8282. Analytes may be removed from Table 1 without additional validation.
SCOPE
1.1 This test method allows for the concentration determination of the pesticides listed in Table 1 and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived (1, 2).2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those which can be classified as hemp. The procedure includes sub-sampling a ground, homogenous sample, liquid-solid extraction with acetonitrile:acetic acid (100:1, v:v), solid phase extraction with C18 SPE media, dilution in 3 mM ammonium formate in water with 0.1 % formic acid and 3 mM ammonium formate in methanol with 0.02 % formic acid in a 20:80 ratio (v:v) and analysis by LC-MS/MS. This procedure encompasses the entire process from sample preparation to analyte quantitation encompassing a range of 0.005 µg/g to 0.500 µg/g.  
Pyrethrins = Pyrethrin I and II
Spinetoram = Spinetoram J and L
Spinosad = Spinosyn A and D
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 Table 1 lists the analytes measured by this test method.  
1.4 No recommendations found within this test method shall preclude observance of federal, state, or local regulations, which may be more restrictive or have different requirements.  
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.

SIGNIFICANCE AND USE
5.1 The sample preparation procedure for comminution impacts other downstream processes such as extraction and sonication, which ultimately affects the total analytical error (TAE) and measurement uncertainty.  
5.2 Factors that may influence the sample preparation process include the prevention of cross-contamination (carryover) from a prior sample and an inadequate cleaning procedure between preparation of samples, poor sample handling, storage (sample preservation), and moisture content (drying methods) of plant material being greater than 15 % (15). Samples with high moisture content are hard to process completely and may yield lower analyte (that is, cannabinoid) concentration during extraction and further processing. Lastly, water activity Specification D8197 is recommended, activity (aw) range (0.55 to 0.65) for dry cannabis or hemp flower or both.  
5.3 There are many different types of hardware technologies that address the comminution of dried cannabis or hemp; however, the list of devices is exhaustive and thus beyond the scope of this guide. See Table 3 and Table 4  (16-18) for a summary of different milling technologies. Distinctions among various pieces of equipment often relate to the type, mass, and size/shape of the sample (dry, fibrous) for which each is most effective. In addition, there may be economic reasons for mill selection, that is, the sample throughput of the testing laboratory (number of samples per day), access to cryogenics, and sample mass requirements.    
5.4 In addition to sampling devices, this guide does not include the sample preparation of edibles, tinctures, oils/concentrates, beverages, and so forth in which the sample diversity poses significant sample preparation challenges to be put forward in additional work items.  
5.5 The sample size for comminution purposes is limited as the analytical testing portion required is often 500 times smaller than the bulk sample lot and not every testing laboratory is equipped to handl...
SCOPE
1.1 In this guide, the basic steps in obtaining a test portion sample of either dried cannabis/hemp inflorescence are outlined.  
1.2 Sample preparation depends on many factors including moisture (dryness) of the sample, the analyte to be measured, the concentrations/amounts, and the test method's precision and accuracy requirements. In this case, dried cannabis or hemp plant material require particle size reduction-comminution from a representative sample of which the final analytical testing portion is determined by the employed testing method. Local regulatory guidelines often dictate both the representative sample that is taken from the bulk material (harvest batch) and the final mass of the test portion (for example  
1.3 This guide will not purport to meet every local and state jurisdiction since different regulatory requirements vary; the local/state requirements are at the discretion of the user to follow and interpret.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
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.

SIGNIFICANCE AND USE
5.1 Medical and/or recreational marijuana (cannabis) has been legalized for adult use in many countries and states within the USA (5). Many jurisdictions that permit the use of medicinal and recreational marijuana require testing of cannabis and associated products to ensure safety from contaminants, especially the toxic “big four” elements such as As, Cd, Hg, and Pb (6), and other metals worthy of consideration (6). These heavy metals can accumulate in plants grown in polluted soils or contamination can occur during the manufacturing process (7). In addition to ensuring product safety, the analysis of mineral and other trace elements is required for labeling purposes when these products are sold as nutritional supplements. Trace element analysis of plant and nutritional supplement materials is a well-established application (8). Following acidic digestion to break down the plant-based samples' primary components, ICP-MS is often used for quantitative analysis because of its multi-element capability, high sensitivity, speed, robustness, and wide dynamic range.  
5.2 This test method covers the rapid determination of multiple elements in cannabis sample digests. The elements include the priority toxic elements (As, Cd, Hg, and Pb), as well as elements required by some states and elements of interest in the cannabis community (V, Cr, Cu, Zn, Sb, Ba, Se, Ag, Na, Al, K, Mn, Fe, Co, Ni, Mo, Tl, Th, and U). Irrespective of the number of elements being measured, test times are approximately a few minutes per test specimen, and detectability for most elements is in the low- to sub-ppb range.
SCOPE
1.1 This test method uses inductively coupled plasma mass spectrometry (ICP-MS) to determine multiple trace elements in cannabis and cannabis-related matrices following sample preparation using microwave-assisted acid digestion. This test method is applicable to the quantification of trace levels of elements in dried plant materials, concentrates, oils, extracts, tinctures of cannabis and cannabis-related products. Other matrices may be added provided that the lab validates the extra matrices using Practice D8282. Details are provided on the validation of both the sample preparation procedure and analytical method using certified reference materials (CRMs) and validation of the analytical method using spike recovery testing of several cannabis based samples.  
1.2 This test method should be used by analysts experienced in the use of microwave digestion and ICP-MS, matrix interferences, and procedures for their correction or reduction, and should only be used by personnel trained in the handling, preparation, and analysis of samples for the determination of trace elements in cannabis and cannabis products (1).2 This test method was developed using a single quadrupole ICP-MS equipped with a collision/reaction cell (CRC) that can be pressurized with helium (He) gas for the removal of polyatomic interferences using kinetic energy discrimination (KED). This test method can also be run using a triple quadrupole or “tandem” mass spectrometer (MS/MS) ICP-MS instrument, which is fitted with CRC technology. The ICP-MS method accounts for polyatomic interferences, which are the most common spectral overlaps in ICP-MS, isobaric interferences, and any potential doubly-charged ion interferences (M2+) that may arise from the presence of rare earth elements (REEs) in the samples, as the REE2+ ion interferences can affect the accuracy of the measurement of arsenic (As) and selenium (Se) in the samples. Table 1 lists elements for which the test method applies along with recommended analytical masses, and secondary masses for some elements. The priority toxic elements arsenic (As), cadmium (Cd), mercury (Hg), and lead (Pb), also sometimes referred to as the “big four” toxic trace elements are listed separately because of their toxicity, as discussed in 5.1.  
1.3 Certified reference materials (CRMs) should be matrix matc...

SIGNIFICANCE AND USE
5.1 Gas chromatography and flame ionization detection provides a rapid means to identify and quantify cannabinoids in a variety of samples of interest. This test method allows producers of cannabis products to improve and optimize the quality of their products. For example, hemp extractors can use it to determine the efficiency of extraction processes and to verify that products meet regulatory requirements, ensuring safety and quality of products.  
5.2 Cannabinoids, such as CBD and THC can be monitored throughout the production process. The determination of Δ9-THC is often required for regulatory purposes and the determination of other THC isomers is often of interest. The United Nations Office on Drugs and Crime provides experimental details and guidance for use of GC to analyze cannabis related samples, including conditions suitable for decarboxylation of cannabinoid acids.3  
5.3 Post-decarboxylated methodology is used. In decarboxylation, heat is used to liberate carbon dioxide from carboxylic acid cannabinoids, forming their corresponding neutral cannabinoids, for example, THC from THCA. It should be recognized that the hot temperature of the GC injection port itself is capable of effecting at least some decarboxylation (250 °C – Table 2), and many sample types, such as distillates, require no decarboxylation because it would have occurred during material processing. Therefore, some knowledge of sample properties and material processing is useful. Resulting determinations are for the total cannabinoid content of specific isomers, for example, total Δ9-THC. For those samples requiring decarboxylation, the method is validated per Practice D8282 through the use of reference materials, spike and recovery of knowns, or through comparison with LC results. For example, carrying out the decarboxylation procedure of a standard containing known amounts of CBDA and CBN should yield the correct amounts of CBD and CBN, where CBN is not significantly changed and the mass...
SCOPE
1.1 This test method covers the analysis of cannabinoids in cannabis products by gas chromatography (GC) and flame ionization detection (FID).  
1.2 This test method is applicable to cannabis raw materials and resin cannabis products as defined in Guide D8245, including those from hemp. Such material includes: biomass; plant material; flowers; resins; extracts; distillates; recovered solvents; and other intermediate processing material. The applicable concentration range of analysis will vary to some extent depending on the nature of the sample, for instance measurement of delta-9-tetrahydrocannabinol (Δ9-THC) for regulatory purposes in hemp would require calibration to lower concentration levels compared to measurement of CBD in its isolate; however, in most cases, the test method is applicable to the determination of major and minor cannabinoids above about 0.1 mass% in concentration. Dilution of sample solutions is used to adjust concentrations to fall within appropriate calibration curves. Particular emphasis is placed on the determination of Δ9-THC for regulatory compliance purposes and control. This test method can measure any cannabinoid that is eluted and detected from a GC column with sufficient resolution from any interfering compounds. Typical cannabinoids of interest that can be determined by this test method are shown in Table 1. Use of an HPLC technique is recommended if individual measurement of acids, such as THCA, is required.  
1.3 The test method does not purport to identify all individual cannabinoids; however, individual users can adapt this test method for specific custom analyses to meet their needs.  
1.4 Units—Values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
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 t...

SIGNIFICANCE AND USE
4.1 Stability testing provides evidence on how the quality and safety of cannabis-based product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. The stability testing will also establish a re-test period for the cannabis product or a shelf-life for the cannabis product under recommended storage conditions. Recommended test conditions are based on ICH Q1A.  
4.2 The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the European Commission (EC), Japan and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV.  
4.3 Requirements of regulatory bodies or governmental departments supersede the recommendations in this guide.
SCOPE
1.1 This guide is applicable to commercial processors and manufacturers engaged in the processing, testing, packaging, labeling, and storage of cannabis products intended for human consumption, including those derived from hemp. Hemp seed and products derived from hemp seed are excluded from the scope of this guide This guide describes the minimum requirements for conducting stability testing of new cannabis products with the purpose of determining appropriate storage conditions and shelf-life.  
1.2 This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use, regardless of the type of cannabis plant from which they were derived.  
1.3 Units—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.

SIGNIFICANCE AND USE
4.1 Laboratories are integral to cannabis/hemp industry operations and consumer safety and satisfaction. Standardized laboratory practices play a key role in establishing and demonstrating product safety, quality, and compliance with the regulations that govern product quality and safety.  
4.2 This guide is intended for use by laboratories as an overview of best practices for operations providing support to the cannabis/hemp industry and its many products. This guide is based on the best practices as articulated in the FOCUS (Foundation of Cannabis Unified Standards) and AHPA (American Herbal Products Association) standards, as well as GMP compliance guidelines.5, 6  
4.3 The contents of this guide reflect the typical requirements imposed by different laboratory regulatory guidelines. It provides recommendations to laboratory operations, GMP, personnel competency, proficiency testing, facility operations, security, sample transfer and receipt, sample handling and disposal, equipment and reagent considerations, reference standards, analytical procedures, data processing and handling, quality assurance, traceability, and accreditation recommendations.  
4.4 This guide is recommended for use by cannabis/hemp laboratory personnel involved in cannabis/hemp laboratory operations.
SCOPE
1.1 This guide provides recommendations for a laboratory licensed or otherwise designated to provide analytical support within the cannabis/hemp industry. Within the scope of this guide, the term cannabis/hemp is inclusive of hemp plants and derived products. This guide presents best laboratory practices, recommended certifications, recommended types of analyses typically required in the cannabis/hemp industry, and recommended quality functions associated with laboratories supporting the cannabis/hemp industry.  
1.2 These recommendations establish a basis for oversight for the analytical testing of cannabis/hemp products. This guide was developed as a complement to existing best practices and, in supporting conformance to current good manufacturing practices (GMP), which are typically required regulatory practices relevant to the cannabis/hemp industries; these recommendations focus on the personnel, security, sample handling and disposal, quality support, data management and reporting activities.  
1.3 This guide generally describes the properties of cannabis/hemp, and cannabis/hemp/cannabis-hemp-derived products to be analyzed.  
1.4 No recommendations found within this guide shall preclude observance of regulations from authorities having regional jurisdiction, which may be more restrictive or have different requirements.  
1.5 This guide applies to all cannabis/hemp containing products commercially manufactured and distributed for consumer use.  
1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.7 This guide does not purport to address all laboratory safety concerns associated with its use. It is the responsibility of the user of this guide to establish appropriate safety and health practices, maintain all safety data sheets (SDS), and document safe practices through work instructions and standard operating procedures (SOPs).  
1.8 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.  
1.9 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.

SIGNIFICANCE AND USE
5.1 This standard will provide best practices for the sampling of harvested cannabis inflorescence with the intent to assure representative sampling.  
5.2 The laboratory results and their respective harvest batch associations have implications and significance to regulatory requirements, quality control considerations throughout the product’s life cycle, and the safety of the consumers who may be adversely affected by consumption of product that was not tested in a homogeneous manner (3).  
5.3 This standard does not address the appropriate sampling of processed cannabis materials such as such as extracts, seeds, edibles, topicals, etc.  
5.4 This standard addresses the sampling of cannabis inflorescence destined for human or animal consumption.  
5.5 This standard does not address pre-harvest field sampling or large untrimmed or unprocessed harvest batches.
SCOPE
1.1 Cannabis harvested materials require sampling strategies throughout their life cycle, from cultivation to the end consumer. For purposes of this standard, the term cannabis is inclusive of all cannabis inflorescence, including hemp varieties. The qualitative and quantitative characteristics of cannabis/hemp for human or animal consumption has safety implications throughout the life cycle from cultivation to end consumer. This standard provides best practice procedures and protocols for sampling batches of harvested cannabis inflorescence. Cannabis/hemp materials often exhibit variability across different parts within the same plant or across different plants within the same cultivar, or both, (1, 2).2 Thus, sampling strategies are required which yield a representative a sample across a harvest batch. Representative sampling is required to ensure that the qualitative and quantitative test results accurately reflect cannabinoid identification, potency, identification and concentration of terpenes, concentration of trace metals, microbiological activity, mycotoxins, and concentration of pesticides across the batch.  
1.2 Where procedural aspects of this practice differ from local regulatory or jurisdictional requirements, the local regulatory or jurisdictional authority’s directives shall take precedence.  
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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.

SIGNIFICANCE AND USE
4.1 The demonstration that a method of analysis is fit for its intended purpose and application is done through method characterization and validation.  
4.2 Resulting SOPs should be reproducible under the same conditions by a different analyst working in a different laboratory.  
4.3 Test methods are designed to assess one or more of the following product attributes: identity, strength or concentration, quality, and purity.  
4.4 The steps of this practice contain the basic procedures for performing a TMC, a TMV, and a TMT. It is not imperative that each procedural step be followed in the designated order, but the ordered sequence is a logical progression of the steps for performing a TMC, a TMV, and a TMT.
SCOPE
1.1 The quality, efficacy, and safety of cannabis and products containing cannabis extracts shall be evaluated by validated testing methodologies used by trained staffed utilizing qualified instruments and/or materials.  
1.2 This practice provides the cannabis industry with guidance for the development and validation of testing methods that adequately evaluate cannabis and products containing cannabis extracts for quality, efficacy, and consumer health safety in the absence of validated methods from agencies. This includes, but is not limited to, the potency of active substances and adulteration, including impurities stemming from potential adulteration during agricultural or manufacturing processes or both (for example, pesticides, residual solvents, and the presence of fungus and microorganisms) before product approval and release for use. Depending on the methodology and precision and accuracy required, these methods may be both qualitative or quantitative.  
1.3 This practice shall define the procedures for test method characterization (TMC), test method validation (TMV), and test method transfer/transfer of analytical procedures (TMT/TAP) of biological, chemical spectroscopic, and physical-based laboratory test methods.  
1.4 Depending on the nature of the test in question (chemical, microbiological, etc.) different variables will need to be considered for validation. The particular variables subject to consideration are beyond the scope of this document. Refer to Guide E2857 for more guidance.  
1.5 This standard does not consider the specifics of acceptable test method limits and users should consult relevant standard literature to determine the appropriate test parameters.  
1.6 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.  
1.7 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.

SIGNIFICANCE AND USE
5.1 The analysis and reporting of cannabinoid content in cannabis and hemp is required to address human health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions. This test method is useful in providing quantitative results for up to seventeen cannabinoids in dried cannabis and hemp raw material samples.
SCOPE
1.1 This test method allows for the concentration determination of the cannabinoids listed in Table 1, and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived.2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those that can be classified as hemp. The procedure includes sub-sampling a ground, homogeneous sample, extraction with methanol:water (80:20, v:v),3,4 dilution in methanol and analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). The method allows for a wide-range of sample concentrations to be determined by using a 1000-fold calibration range and the option to perform multiple levels of sample dilution. The calibration curve is prepared in methanol over a range of 10 ng/mL to 10 000 ng/mL for all seventeen cannabinoids, or a subset of cannabinoids if desired, while the sample extracts are diluted in methanol into the calibration range.3,4,5 For example, a 1/500 dilution of sample extracts allows concentration determination over a range of 0.5 mg/g to 500 mg/g in cannabis. The method was validated with quality control samples prepared in methanol, a candidate certified reference material (CRM), and repeat analysis of cannabinoid samples.3  
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 List of Measurable Analytes—See Table 1.  
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.

SIGNIFICANCE AND USE
5.1 The analysis and reporting of pesticide content in all forms of cannabis raw material that is grown or processed or both, with the intent of ingestion or consumption, is required to address health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions where cannabis has been legalized for ingestion or consumption for medicinal or recreational purposes, or both. This test method is useful in providing quantitative results for the analytes listed in Table 1, which is a subset of the pesticide testing requirements found in regulatory documents for cannabis, not limited to and including Canada, many U.S. states where legalization has occurred, and the European Pharmacopeia (1-4). This test method may be appropriate for additional pesticide and growth regulator analytes, which may be added to those of Table 1 provided validation is performed in accordance with Practice D8282. Analytes may be removed from Table 1 without additional validation.
SCOPE
1.1 This test method allows for the concentration determination of the pesticides listed in Table 1 and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived (1, 2).2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those which can be classified as hemp. The procedure includes sub-sampling a ground, homogenous sample, liquid-solid extraction with acetonitrile:acetic acid (100:1, v:v), solid phase extraction with C18 SPE media, dilution in 3 mM ammonium formate in water with 0.1% formic acid and 3 mM ammonium formate in methanol with 0.02% formic acid in a 20:80 ratio (v:v) and analysis by LC-MS/MS. This procedure encompasses the entire process from sample preparation to analyte quantitation encompassing a range of 0.005 µg/g to 0.500 µg/g.  
Pyrethrins = Pyrethrin I and II
Spinetoram = Spinetoram J and L
Spinosad = Spinosyn A and D
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 Table 1 lists the analytes measured by this test method.  
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.

SIGNIFICANCE AND USE
4.1 Laboratories are integral to cannabis/hemp industry operations and consumer safety and satisfaction. Standardized laboratory practices play a key role in establishing and demonstrating product safety, quality, and compliance with the regulations that govern product quality and safety.  
4.2 This guide is intended for use by laboratories as an overview of best practices for operations providing support to the cannabis/hemp industry and its many products. This guide is based on the best practices as articulated in the FOCUS (Foundation of Cannabis Unified Standards) and AHPA (American Herbal Products Association) standards, as well as GMP compliance guidelines.5, 6  
4.3 The contents of this guide reflect the typical requirements imposed by different laboratory regulatory guidelines. It provides recommendations to laboratory operations, GMP, personnel competency, proficiency testing, facility operations, security, sample transfer and receipt, sample handling and disposal, equipment and reagent considerations, reference standards, analytical procedures, data processing and handling, quality assurance, traceability, and accreditation recommendations.  
4.4 This guide is recommended for use by cannabis/hemp laboratory personnel involved in cannabis/hemp laboratory operations.
SCOPE
1.1 This guide provides recommendations for a laboratory licensed or otherwise designated to provide analytical support within the cannabis/hemp industry. Within the scope of this guide, the term cannabis/hemp is inclusive of hemp plants and derived products. This guide presents best laboratory practices, recommended certifications, recommended types of analyses typically required in the cannabis/hemp industry, and recommended quality functions associated with laboratories supporting the cannabis/hemp industry.  
1.2 These recommendations establish a basis for oversight for the analytical testing of cannabis/hemp products. This guide was developed as a complement to existing best practices and, in supporting conformance to current good manufacturing practices (GMP), which are typically required regulatory practices relevant to the cannabis/hemp industries; these recommendations focus on the personnel, security, sample handling and disposal, quality support, data management and reporting activities.  
1.3 This guide generally describes the properties of cannabis/hemp, and cannabis/hemp/cannabis-hemp-derived products to be analyzed.  
1.4 No recommendations found within this guide shall preclude observance of regulations from authorities having regional jurisdiction, which may be more restrictive or have different requirements.  
1.5 This guide provides guidelines for laboratories supporting compliance GMP.  
1.6 This guide applies to all cannabis/hemp containing products commercially manufactured and distributed for consumer use.  
1.7 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.8 This guide does not purport to address all laboratory safety concerns associated with its use. It is the responsibility of the user of this guide to establish appropriate safety and health practices, maintain all safety data sheets (SDS), and document safe practices through work instructions and standard operating procedures (SOPs).  
1.9 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.  
1.10 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 (T...

SIGNIFICANCE AND USE
4.1 Laboratories are integral to cannabis industry operations and consumer safety and satisfaction. Standardized laboratory practices play a key role in establishing and demonstrating product safety, quality, and compliance with the regulations that govern product quality and safety.  
4.2 This guide is intended for use by laboratories as an overview of best practices for operations providing support to the cannabis industry and its many products. This guide is based on the best practices as articulated in the FOCUS (Foundation of Cannabis Unified Standards) and AHPA (American Herbal Products Association) standards, as well as GMP compliance guidelines.5,6  
4.3 The contents of this guide reflect the typical requirements imposed by different laboratory regulatory guidelines. It provides recommendations to laboratory operations, GLP, GMP, personnel competency, proficiency testing, facility operations, security, sample transfer and receipt, sample handling and disposal, equipment and reagent considerations, reference standards, analytical procedures, data processing and handling, quality assurance, traceability, and accreditation recommendations.  
4.4 This guide is recommended for use by cannabis laboratory personnel in management, quality assurance, regulatory compliance, quality control, and personnel training capacities.
SCOPE
1.1 This guide provides recommendations for a laboratory licensed or otherwise designated to provide analytical support within the cannabis industry. Within the scope of this guide, the term cannabis is inclusive of hemp plants and derived products. This guide presents best laboratory practices, recommended certifications, recommended types of analyses typically required in the cannabis industry, and recommended quality functions associated with laboratories supporting the cannabis industry.  
1.2 These recommendations establish a basis for oversight for the analytical testing of cannabis products. Developed as a complement to existing good laboratory practices (GLP) and supporting conformance to current good manufacturing practices (GMP), these recommendations focus on the personnel, security, sample handling and disposal, quality support, data management, and reporting activities.  
1.3 This guide generally describes the properties of cannabis and cannabis-derived products to be analyzed and recommends the types of testing required.  
1.4 No recommendations found within this guide shall preclude observance of federal, state, or local regulations, which may be more restrictive or have different requirements.  
1.5 This guide provides guidelines for compliance with good laboratory practices (GLP) and good manufacturing practices (GMP) quality applications.  
1.6 This guide applies to all cannabis-containing products commercially manufactured and distributed for consumer use.  
1.7 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.8 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.  
1.9 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.