SPDS eBook March 2017

Original Fitness for Purpose Statement (Working Group Launch 09/16/2016) The method must quantitate the pungent principles derived from the rhizome of ginger, Zingiber officinale Roscoe. The method must quantitate, at a minimum, 6-, 8-, and 10- gingerols and 6-shogaol. The method should preferably quantitate 8- and 10- shogaols, as well as 6- and 10-paradols, 6- and 10- gingerdiols, 6- , 8-, and 10- gingerdiones and zingerone. Individual constituents should be quantifiable within the range of 0.01% and 50% by weight in powdered ginger rhizome, ginger rhizome dry and soft extracts, and ginger-containing finished products including capsules and tablets in the presence of common excipients. The ability to address softgels and tinctures is advantageous, but optional. No limit on analysis time is imposed. 3 anb@usp.org 03/17/2017

Ginger Working Group Work to Date

• In‐Person Launch Meeting  (September 16, 2016  at the AOAC Annual Meeting, Dallas, TX) • 2 Teleconferences (October 27 & November 10, 2016) • 1 SMPR Drafted: Quantitation of Select  Nonvolatile Ginger Constituents • Public comment period: December 23, 2016 – January 27, 2017.   No public comments received . • SMPR is ready for SPDS review and approval  4 anb@usp.org 03/17/2017