Standard Specification for Medicinal-use Cannabis Inflorescence

SCOPE
1.1 This standard defines the specifications (appropriate tests, their analytical methods and acceptance criteria) for the identification, strength (for example, cannabinoid content), and purity (for example, limits for contaminants) for medicinal-use cannabis inflorescence.  
1.2 This specification references approved analytical methods used to verify the specifications, and in the absence of approved analytical methods, a suggested method for validating such specifications.  
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.

General Information

Status
Published
Publication Date
31-Aug-2022
Technical Committee
Current Stage
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ASTM D8439-22 - Standard Specification for Medicinal-use Cannabis Inflorescence
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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.
Designation:D8439 −22
Standard Specification for
1
Medicinal-use Cannabis Inflorescence
This standard is issued under the fixed designation D8439; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D8244GuideforAnalyticalLaboratoryOperationsSupport-
ing the Cannabis/Hemp Industry
1.1 This standard defines the specifications (appropriate
D8270Terminology Relating to Cannabis
tests, their analytical methods and acceptance criteria) for the
D8282Practice for Laboratory Test Method Validation and
identification,strength(forexample,cannabinoidcontent),and
Method Development
purity(forexample,limitsforcontaminants)formedicinal-use
D8334 Practice for Sampling of Cannabis/Hemp Post-
cannabis inflorescence.
Harvest Batches for Laboratory Analyses
1.2 This specification references approved analytical meth-
ods used to verify the specifications, and in the absence of
3. Terminology
approved analytical methods, a suggested method for validat-
3.1 Definitions are in accordance with Terminology D8270
ing such specifications.
unless otherwise indicated.
1.3 Units—The values stated in SI units are to be regarded
3.2 Definitions:
asstandard.Nootherunitsofmeasurementareincludedinthis
3.2.1 cannabis inflorescence, n—fruiting tops of a cannabis
standard.
plant (excluding the seeds and leaves when not accompanied
1.4 This standard does not purport to address all of the
by the tops) from which the resin has not been extracted, by
safety concerns, if any, associated with its use. It is the
whatevernametheymaybedesignatedbytheauthorityhaving
responsibility of the user of this standard to establish appro-
jurisdiction.
priate safety, health, and environmental practices and deter-
3.2.2 total CBD, n—the amount of CBD that considers the
mine the applicability of regulatory limitations prior to use.
potential of CBDA to convert quantitatively to CBD with no
1.5 This international standard was developed in accor-
further degradation, using the following formula:
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
TotalCBD=CBD+0.877 3CBDA
Development of International Standards, Guides and Recom-
3.2.3 total THC, n—the amount of THC that considers the
mendations issued by the World Trade Organization Technical
potential of ∆9-THCA to convert quantitatively to THC with
Barriers to Trade (TBT) Committee.
no further degradation, using the following formula:
TotalTHC=THC+0.877 3THCA
2. Referenced Documents
2
3.3 Acronyms:
2.1 ASTM Standards:
3.3.1 ADI, n—acceptable daily intake
D8196Practice for Determination of Water Activity (a )in
w
Cannabis Flower
3.3.2 AHJ, n—authority having jurisdiction
D8197Specification for Maintaining Acceptable Water Ac-
3.3.3 CBD, n—cannabidiol (CAS #: 13956-29-1)
tivity (a ) Range (0.55 to 0.65) for Dry Cannabis Flower
w
3.3.4 CBDA, n—cannabidiolic acid (CAS #: 1244-58-2)
Intended for Human/Animal Use
D8219Guide for Cleaning and Disinfection at a Cannabis
3.3.5 CBN, n—cannabinol (CAS #: 521-35-7)
Cultivation Center
3.3.6 CBNA, n—cannabinolic acid (CAS #: 2808-39-1)
3.3.7 PDE, n—permitted daily exposure
1
This specification is under the jurisdiction of ASTM Committee D37 on
3.3.8 THC or ∆-9-THC, n—delta-9-tetrahydrocannabinol
CannabisandisthedirectresponsibilityofSubcommitteeD37.04onProcessingand
(CAS #: 1972-08-3)
Handling.
Current edition approved Sept. 1, 2022. Published October 2022. DOI: 10.1520/
3.3.9 THCA or ∆-9-THC-A, n—delta-9-
D8439-22.
tetrahydrocannabinolic acid (CAS #: 23978-85-0)
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3.3.10 USP, n—United States Pharmacopeia
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. 3.3.11 WHO, n—World Health Organization
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D8439−22
4. Significance and Use 6. Cultivation and Storage Practices
4.1 Significance: 6.1 Medicinal-usecannabisinflorescenceshallbecultivated
under defined protocols following sanitation practices as ar-
4.1.1 This specification defines the metrics for
identification, cannabinoid specifications, and limits for con- ticulated in Guide D8219 and cultivated in accordance with an
appropriatequalitymanagementsystemsuchasGo
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