SPDS Lutein and Turmeric ERPs

General Information

Reviewer Name:

Aniko Solyom

Email:

asolyom@gaasanalytical.com

Organization:

GAAS Analytical

Method Reviewed:

LUT‐01

Method Title:

Quantitative measurement of Beta‐ Cryptoxanthin in Paprika oleoresin, extract and  dietary supplements

Applicable SMPR

2016.004

I.  Summary

Summary of Method:

The method quantifies the amount of beta‐cryptoxanthin and total xantophyllis in  paprika oleoresin, extracts and dietary supplement beadlets.

1.  Does the Applicability of the  Method Support the Applicability  of the SMPR?  If not, please explain  what is missing. II.  Review of the Method Only 2.  Does the analytical technique(s)  used in the method meet the  SMPR?  If not, please specify how it  differs from what is stated in the  SMPR. 3.  Are the definitions specified in  the SMPR used and applied  appropriatly in the method?  If no,  please indicate how the terms are  used. 4.  Does the method, as written,  contain all appropriate precautions  and warnings related to the  method's regaents, components,  instrumentation, or method steps  that may be hazardous?  If no,  please suggest wording or  option(s). 1.  Are the definitions specified in  the SMPR used and applied  appropriately in the supporting  documentation (manuscripts,  method studies, etc…)?  If not,  please explain the differences and  if the method is impacted by the  difference.  

Partly. (i) According to the  SMPR the method should be able to separately quantify  cis and trans isomers of each analytes ‐ the method quantifies beta‐cryptoxanthin,  without cis/trans distinction. (I believe  the SMPR is a bit too ambitious with this  requirement.)  (ii) The method quantifies only beta‐cryptoxanthin but not the rest of the analytes  (lutein and zeaxanthin), but it can be still acceptable.

Yes

Yes

There is no separate safety section in the description, but the chemicals and  instruments are commonly used in a routine analytical laboratory.

III.  Review of Information in Support of the Method

Yes, except the analytical range.