ASTM_D_8309_-_21.pdf

Designation:D830921Standard Guide forStability Testing of Cannabis-Based Products1This standard is issued under the fixed designation D8309;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 guide is applicable to commercial processors andmanufacturers engaged in the processing,testing,packaging,labeling,and storage of cannabis products intended for humanconsumption,including those derived from hemp.Hemp seedand products derived from hemp seed are excluded from thescope of this guide This guide describes the minimum require-ments for conducting stability testing of new cannabis productswith the purpose of determining appropriate storage conditionsand shelf-life.1.2 This guide applies to all cannabis-derived productscommercially manufactured and distributed for consumer use,regardless of the type of cannabis plant from which they werederived.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:2D8270 Terminology Relating to CannabisD8282 Practice for Laboratory Test Method Validation andMethod Development2.2 ICH Documents:3Q1A(R2)Harmonised Tripartite Guideline Stability Test-ing of New Drug Substances and ProductsQ1B Harmonised Tripartite Guideline Stability Testing:Photostability Testing of New Drug Substances and Prod-ucts3.Terminology3.1 Definitions:3.1.1 For definitions of terms,see Terminology D8270.3.2 Definitions of Terms Specific to This Standard:3.2.1 accelerated testing,nstudies designed to increasethe rate of chemical degradation or physical change of aproduct by using exaggerated storage conditions as part of theformal stability studies.3.2.1.1 DiscussionData from these studies,in addition tolong term stability studies,can be used to assess longer termchemical effects at non-accelerated conditions and to evaluatethe effect of short-term excursions outside the label storageconditions(for example,during shipping).Results from accel-erated testing studies are not always predictive of physicalchanges.3.2.2 cannabis product,nproducts derived from the can-nabis plant(flowers or resins)that are intended for humanconsumption and are packaged and labeled in their final formfor marketing.3.2.3 climatic zones,nthe four zones in the world that aredistinguished by their characteristic prevalent annual climaticconditions.3.2.3.1 DiscussionZone 1 is temperate,Zone II issubtropical,Zone III is hot dry,and Zone IV is hot humid/tropical.This is based on the concept described by Grimm,1985 and 1986.43.2.4 D65/ID65,nan illuminant standard used to representdaylight as defined by the International Commission on Illu-mination.1This guide is under the jurisdiction of ASTM Committee D37 on Cannabis andis the direct responsibility of Subcommittee D37.03 on Laboratory.Current edition approved June 1,2021.Published July 2021.DOI:10.1520/D8309-21.2For 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.3Available from International Council for Harmonisation of Technical Require-ments for Pharmaceuticals for Human Use(ICH),ICH Secretariat,Route dePr-Bois,20,P.O Box 1894,1215 Geneva,Switzerland,https:/www.ich.org.4Grimm,W.,Drugs Made in Germany,Vol 28,pp.196202,1985,and Vol 29,pp.3947,1986.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.13.2.4.1 DiscussionID65 is the indoor equivalent of theD65 standard.53.2.5 expiration date,nthe date placed on the packagingor label,or both,that displays the time period during which theproduct is known to remain stable,which means it retains itsstrength,quality,and purity when it