The proposal is based on the version of the monograph official prior to 2013. On the basis of comments received, the previous proposal that appeared in PF 44.6 [Nov.–Dec. 2018] was cancelled and is replaced with the following proposal. It is suggested to revise the monograph with the following changes:
Add a Note before the Identification stating that dronabinol is delta-9-tetrahydrocannabinol (THC) for clarity. In addition, delta-9-THC was changed to dronabinol when appropriate for consistency.
Add Identification B based on the UV spectrum of the major peak obtained from the Assay.
Add a Note in the Assay to minimize exposure to air and light.
Update the Detector specifications in the Assay to support the proposed Identification B.
Add the use of a cartridge as guard column to the Assay to provide flexibility.
Replacing the SST in the Assay with a new one using USP delta-8-THC RS as Reference Standard.
Revise SST requirements for relative standard deviation from max. 2.0% to max. 1.0% to be consistent with the expectations for modern chromatographic systems.
Update the Rupture Test and clarify the wording for the tolerances (Performance Test).
Add a Dissolution test with a specific liquid chromatographic procedure.
Add a test for Organic Impurities (e.g., CBN max. 1.0%, delta-8-THC max. 2.0%) with a specific liquid chromatographic procedure.
Update the Packaging and Storage section (preserve in well-closed, light-resistant containers, in a cool place, protect from freezing).
Add USP delta-8-THC RS and USP Sesame Oil RS to the USP Reference Standards section to support the revised Assay and proposed test for Organic Impurities.
The proposed USP monograph Dronabinol Capsules is available after registration to the Pharmacopeial Forum.