Draft SMPR (Version 2)
Method Performance Requirements
5
Analytical range
1 – 1300*
Limit of Quantitation (LOQ)
≤ 1*
Recovery
90‐110%
Repeatability (RSD
r
)
1-100
≤ 8%
*μg /100 g reconstituted final
product.
a) ‘ready‐to‐feed” liquids “as
is”
>100
≤ 5%
Reproducibility (RSD
R
)
1-100
≤ 15%
>100
≤ 10%
b) reconstituted powders (25
g into 200 g of water); and
c) liquid concentrates diluted
1:1 by weight.
Stakeholder Comments
Summary of comments
6
Joseph Schierle
(DSM Nutritional Products)
1) Questions the need for separation of
cis
isomers of α‐carotene from those of β‐
carotene.
2) Suggests adding zeaxanthin to the scope.
3) Questions the need for a low LOQ of 1 μg/100 g.
4) Comments that the proposed repeatability and reproducibility numbers are very
challenging.
Neal Craft
(Craft Technologies, Inc.)
1) Proposes quantifying
cis
and
trans
isomers of lutein.
2) Proposes adding zeaxanthin to the scope.
3) Proposes making definitions of lutein and lycopene more specific.
4) Suggests that methods specific to xanthophylls or carotenes can be submitted.
