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 previous proposal that appeared in PF 50(3) [May–Jun. 2024] has been canceled and is replaced with this new proposal. On the basis of comments received, add the limit of total unspecified impurities as NMT 0.50% in the test for Organic Impurities. 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-1987
USP REFERENCE STANDARDS FOR PURCHASE
USP Cannabidiol RSUSP Cannabidiol Solution RS
USP Cannabinoids Mixture RS