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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

2

No major concerns over the chemicals involved

Cons/Weaknesses

Spike recoveries on the lutein are all below 100%. Is the method under recovering lutein or is the

saponification too harsh on the sample destroying the lutein?

Supporting Data

General Comment:

Positive that multiple analysts used in SLV

-

Method Optimization:

Were multiple column manufacturers used for C30

Multiple Instruments?

Performance Characteristics:

Analytical Range:

Method meets SMPR requirement

LOQ:

Method Meets SMPR requirement

Accuracy/Recovery:

Recoveries were acceptable except for Lutein. Though they meet the SMPR of 90-110%

requirement, the recoveries are all below 100%.

Precision (RSD

r

):