AOAC SPDS Meeting Book March 19 2015

SMPR Key Points

• 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) – • 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.