1. Scope

Keywords

Rationale

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: ? Provide specifications for cannabinoids produced through precision fermentation, conversion, or chemical synthesis. Specifications shall include 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 cannabinoids produced through precision fermentation, conversion, or chemical synthesis. 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 cannabinoid requirements and regulations.