SPDS Meeting Book

Fitness for Purpose (proposal)

Quantitative measurement of lutein, 3’‐epilutein,  zeaxanthin and β‐cryptoxanthin in both raw  materials from which dosage forms are formulated;  and in finished products (e.g., softgels, beadlets).   Methods must be able to accurately measure in the  analytical range below 1 mg per dosage unit.

Questions to address • Address extraction from botanical tissues? • Esters?  Or  free compounds only  (saponify first)? • Quantify losses: – To epilutein ? – Only all‐ trans  species  (or include  cis  species)? Oxidized species? – • Lutein only, or include: – Zeaxanthin ? – β‐Cryptoxanthin ? – Others?