1. Scope

1. Scope:

1.1. This standard shall define a set of minimum quality specifications for purified cannabinoids intended for human use produced through:

1.1.1. Generation or conversion from other cannabinoids and botanically-derived precursors, i.e. semi-synthetic cannabinoids.

1.1.2. Chemical synthesis, i.e. synthetic cannabinoids.

1.2. This standard shall apply to both novel and non-novel cannabinoids produced through conversion from other cannabinoids and botanically-derived precursors or chemical synthesis.

1.3. This standard shall apply to any purified semi-synthetic or synthetic cannabinoid regardless of regulatory classification.

1.4. This standard shall define a minimum purity concentration and maximum allowable botanically related substances, impurities, and contaminants for semi-synthetic or synthetic cannabinoids.

1.5. This standard shall define test methods for verifying the defined quality attributes are within specification, when test methods are available; otherwise, criteria for the validity of test results shall be defined.

1.6. This standard shall not apply to cannabinoids produced through natural biological mechanisms of animals, i.e. endocannabinoids.

1.7. This standard shall not apply to extracted and refined cannabinoid substances produced through natural biological mechanisms of plants. See USDA, NOP 5033-1 and EMEA, Annex 1 to Regulation EU-2018/848 for definition of natural biological mechanisms.

1.8. This standard shall not apply to consumer-facing cannabinoid products.

1.9. This standard shall not apply to any cannabinoid-based or cannabinoid-containing approved drug product.

1.10. This standard shall not address safety of semi-synthetic or synthetic cannabinoids, and conformance with this standard shall not mean the semi-synthetic or synthetic cannabinoid is safe for human use.

Keywords

Cannabis; hemp; marijuana; THC; CBD; purity; concentration; impurities; contaminants; dronabinol; botanically related substance; natural component; HHC; iso-THC; exo-THC; d8-THC; d8 THC; d9-THC; d9 THC; semi-synthetic; synthetic; converted; precursor; catalyst; reagent; by-product

Rationale

Cannabinoid products that can be regulatorily classified as marijuana or hemp containing both semi-synthetic (converted) and synthetic (artificial) cannabinoids are being sold into the global consumer product marketplace. A lack of harmonized international regulations for cannabinoids and cannabinoid products has led to a wide range of qualities in the market and suspected contamination from incomplete reactions, creation of by-products, and unknown compounds. This lack of regulation has created a dangerous situation where authorities having jurisdiction cannot differentiate between types of cannabinoids whether natural or synthetic. This standard is intended to close this gap by creating a set of minimum quality specifications for semi-synthetic and synthetic cannabinoids.

Considerations for the Voter:

The following specification was developed in collaboration with a diverse group of stakeholders representing cannabinoid synthesis subject matter experts, testing and investigative laboratories, product manufacturers, regulators, and consumers.

The intent of this standard is to:

? Establish structural definitions for different types of cannabinoids.
? Provide specifications for semi-synthetic and synthetic cannabinoids, including minimum concentration, allowable botanically related substances, impurities, and contaminants that must be controlled.
? Outline the test methods for verifying the defined constituents are within specification.

The purpose of this standard is to provide a mechanism for reducing the number of unknown and uncharacterized peaks in a chromatography so that if an adverse event occurs from consuming the synthesized cannabinoid, it can be narrowed down to a singular peak rather than a sea of peaks and unknowns.

This will help prevent concerns related to unknown by-products and incomplete conversions during the manufacturing process. Most safety issues cited by the FDA are directly related to the impurities found in these compounds and not with the compounds themselves.

While most of the input for this standard did come from North America, an effort was made to solicit as much feedback from impacted global marketplaces as possible. This standard is only the beginning and attempts to address a major gap regarding impurity and contaminant specifications for semi-synthetic and synthetic cannabinoids.

Please remember that ASTM International standards are living documents and are intended to be updated and revised over time. This initial version will not be perfect, but it will serve to provide marketplaces with the information they need to make informed decisions regarding requirements and regulations for semi-synthetic and synthetic cannabinoids.

The title and scope are in draft form and are under development within this ASTM Committee.