98 / 172
•
Mitragynine and 7‐hydroxymitragynine are exclusive to
speciosa
– the only 2 alkaloids of interest to the Agency (safety)
physiology/pharm is lagging behind on the other alkaloids (binding data)
SMPR Key Points
–
•
Focus is only on
Mitragyna speciosa
•
Need ‐ a quantitative method for the 2 alkaloids of concern to
the FDA … AND other relevant indole alkaloids for which
standards are available
•
Method should resolve the diasteriosomers
•
Method should be able to handle a variety of matrices based
upon finished forms:
–
tablets, capsules, liquid extracts, concentrated extracts, dry whole leaf,
powder
–
detentions have mostly involved raw botanical form and liquids
Motion
•
Move to accept the Standard Method
Performance Requirements for
Mitragyna
speciosa
as presented.