ASTM_D_8439_-_22.pdf

Designation:D843922Standard Specification forMedicinal-use Cannabis Inflorescence1This standard is issued under the fixed designation D8439;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 indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This standard defines the specifications(appropriatetests,their analytical methods and acceptance criteria)for theidentification,strength(for example,cannabinoid content),andpurity(for example,limits for contaminants)for medicinal-usecannabis inflorescence.1.2 This specification references approved analytical meth-ods used to verify the specifications,and in the absence ofapproved analytical methods,a suggested method for validat-ing such specifications.1.3 UnitsThe values stated in SI units are to be regardedas standard.No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility 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.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization 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:2D8196 Practice for Determination of Water Activity(aw)inCannabis FlowerD8197 Specification for Maintaining Acceptable Water Ac-tivity(aw)Range(0.55 to 0.65)for Dry Cannabis FlowerIntended for Human/Animal UseD8219 Guide for Cleaning and Disinfection at a CannabisCultivation CenterD8244 Guide forAnalytical Laboratory Operations Support-ing the Cannabis/Hemp IndustryD8270 Terminology Relating to CannabisD8282 Practice for Laboratory Test Method Validation andMethod DevelopmentD8334 Practice for Sampling of Cannabis/Hemp Post-Harvest Batches for Laboratory Analyses3.Terminology3.1 Definitions are in accordance with Terminology D8270unless otherwise indicated.3.2 Definitions:3.2.1 cannabis inflorescence,nfruiting tops of a cannabisplant(excluding the seeds and leaves when not accompaniedby the tops)from which the resin has not been extracted,bywhatever name they may be designated by the authority havingjurisdiction.3.2.2 total CBD,nthe amount of CBD that considers thepotential of CBDA to convert quantitatively to CBD with nofurther degradation,using the following formula:Total CBD=CBD+0.8773CBDA3.2.3 total THC,nthe amount of THC that considers thepotential of 9-THCA to convert quantitatively to THC withno further degradation,using the following formula:Total THC=THC+0.8773THCA3.3 Acronyms:3.3.1 ADI,nacceptable daily intake3.3.2 AHJ,nauthority having jurisdiction3.3.3 CBD,ncannabidiol(CAS#:13956-29-1)3.3.4 CBDA,ncannabidiolic acid(CAS#:1244-58-2)3.3.5 CBN,ncannabinol(CAS#:521-35-7)3.3.6 CBNA,ncannabinolic acid(CAS#:2808-39-1)3.3.7 PDE,npermitted daily exposure3.3.8 THC or-9-THC,ndelta-9-tetrahydrocannabinol(CAS#:1972-08-3)3.3.9 THCAor-9-THC-A,ndelta-9-tetrahydrocannabinolic acid(CAS#:23978-85-0)3.3.10 USP,nUnited States Pharmacopeia3.3.11 WHO,nWorld Health Organization1This specification is under the jurisdiction of ASTM Committee D37 onCannabis and is the direct responsibility of Subcommittee D37.04 on Processing andHandling.Current edition approved Sept.1,2022.Published October 2022.DOI:10.1520/D8439-22.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United 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 Barriers to Trade(TBT)Committee.14.Significance and Use4.1 Significance:4.1.1 Thisspecificationdefinesthemetricsforidentification,cannabinoid specifications,and limits for con-taminants for medicinal-use cannabis inflorescence.4.1.2 The specifications cited in this specification are re-ported from multiple global standards as referenced in the textand supported by both the U.S.Pharmacopeias CannabisExpert Panel recommendations as published(1)3and theAmerican Herbal Pharmacopeia(2).As coming from standardsthat are global and currently utilized,the specifications citedherein are considered attainable.4.2 Use:4.2.1 All measurements shall be report