The Identification section has been revised to clarify that the requirements are met by complying with the Identification A for macroscopic and microscopic characteristics, plus one of the following: Identification B (HPTLC), C (HPLC), or D (GC). In addition, a Visual Representation of Chromatographic Identification Procedures is provided for information.
Loss on Drying <731> (max. 10.0%): A method has been included which is performed under vacuum at 40° for 24 h to avoid potential loss and other degradation not related to loss of water (e.g., from decarboxylation of acidic cannabinoids and loss of terpenes).
The proposal does not require "on the dried basis" for expression of cannabinoid content because the term "dried basis" is subject to interpretation differently by different groups (e.g, leading to possible inflation of the labeled cannabinoid content). Thus, the revised monograph proposes that the quantitative analysis is performed on the "as is basis“ at specified water activity level (water activity during storage should be maintained at 0.60 ± 0.05).
The Microbial Contaminants specifications have been revised as follows: - Option 1: Specific acceptance criteria for total aerobic microbial count (TAMC), total combined yeasts/moulds count (TYMC), and specified microorganisms (tests according to USP general chapters <61> and <62>). - Option 2 (particularly for inhalation products): More stringent requirements for TAMC, TYMC, and specified microorganisms based on USP general chapter <1111>. The label should then identify the product as having a reduced microbial load. In addition, the label indicates whether the article has been treated to reduce the microbial load and the method used.
The Content of Terpenes section has been removed from Specific Tests because "there is insufficient information to support the use of terpenes for medical purposes". Terpenes are now mentioned only as constituents of interest (i.e., b-Caryophyllene, D-limonene, b-myrcene, a-pinene, terpinolene).
Stakeholder are invited to send their comments on the above revisions and other sections of the revised proposal to the USP HMC until 1 November 2023.