1,3-Benzenediol, 2-[(1R,6R)-3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-;
(1′R,2′R)-5′-Methyl-4-pentyl-2′-(prop-1-en-2-yl)-1′,2′,3′,4′-tetrahydro-[1,1′-biphenyl]-2,6-diol [13956-29-1]
BRIEFING
Cannabidiol. Because there is no existing USP monograph for this drug substance, a new monograph is being proposed. The proposal for this monograph that appeared in PF 48(1) [Jan.–Feb. 2022] has been canceled and is being replaced with a new proposal. On the basis of comments received, the following changes have been made:
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Replace Procedures 1, 2, 3, and 4 for the Organic Impurities test with a newly proposed method.
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Replace the liquid chromatographic procedure in the Assay with one based on analyses performed with the Thermo Accucore Phenyl-X brand of column with L11 packing. The typical retention time for cannabidiol is about 13.6 min.
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The chromatographic procedure in the test for Organic Impurities was performed using the same chromatographic conditions as the Assay. The typical retention times for cannabidiol and impurities are as follows:
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Remove the test for Specific Rotation because it is not a part of the essential tests for plant-derived cannabidiol nor a specific quality parameter.
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This proposed monograph aims to provide specifications for highly purified Cannabidiol (CBD) from Cannabis sativa. CBD obtained from synthetic routes of production could result in different impurity profiles. This proposal does not include specifications for synthetically derived CBD.
(BDSHM: N.-C. Kim)
Case ID—SUB-521
USP REFERENCE STANDARDS FOR PURCHASE
USP Cannabidiol RSUSP Cannabidiol Solution RS
USP Cannabinoids Mixture RS