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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?