USP HMC Publishes Final Cannabis Flower Monograph

Following the revised draft chapter issued last year, the USP Herbal Medicines Compendium (HMC) published the Final Authorized Version 1.0 of its Cannabis Species Inflorescence Monograph.

Definition

The herbal drug consists of the pistillate (female) inflorescence of Cannabis sativa L. (Fam. Cannabaceae) and its subspecies, varieties, and chemotypes (or all species of Cannabis). The article is derived from homogeneous cultivars to contain min. 90% and max. 110% of the labeled amount (in mg/g) of total tetrahydrocannabinol (THC) including delta9-THC and the corresponding acid; and min. 90% and max. 110% of the labeled amount (in mg/g) of total cannabidiol (CBD) including CBD and the corresponding acid. The article may consist of either one of the following three chemotypes:

• THC-dominant chemotype
• CBD-dominant chemotype
• THC/CBD intermediate chemotype

Microbial Contaminants

The new monograph offers two options for microbial contaminant testing. One uses standard limits, while the other provides stricter limits for at-risk populations, like immunocompromised patients, to minimize infection risks from cannabis inhalation. In addition, the label indicates whether the article has been treated to reduce the microbial load and the method used. In cases where the product conforms to the stricter limits for inhaled use, and in order to aid at-risk populations in choosing lower-risk products, the label should identify the product as having a reduced microbial load.

Heavy Metals

The following acceptance criteria are provided for elemental impurities:

• Arsenic: max. 0.2 ppm
• Cadmium: max. 0.3 ppm
• Lead: max. 0.5 ppm
• Mercury: max. 0.1 ppm

Specific Tests

• Foreign Organic Matter: max. 5% of the sample consists of Cannabis Species Inflorescence stems that are 3 mm or more in
  diameter. Max. 2% of the sample consists of any other foreign organic matter.
• Total Ash: max. 20.0%
• Water Activity: 0.60 ± 0.05
• Loss on Drying (LOD): max. 10.0%  

For more information please go to the USP Herbal Medicines Compendium.