SPDS Lutein and Turmeric ERPs

Reviewer Name: General Information

Yang Zhou

Email:

yangzhou@eurofinsus.com

Organization:

Eurofins

Method Reviewed:

LUT‐01

QUANTITATIVE MEASURMENT OF BETA‐CRYPTOXANTHIN IN PAPRIKA OLEORESIN,   EXTRACT AND DIETARY SUPPLEMENTS (BEADLETS)

Method Title:

Applicable SMPR

2016.004

I.  Summary

Summary of Method:

Based on the sample matrix (paprika oleoresin, extract, or dietary supplement) and  detection instrumentation (HPLC or UV), samples are extracted with corresponding  extraction solvent. Saponification is performed for paprika oleoresin. The extraction  solvent is then quantified by HPLC or UV reading.

1.  Does the Applicability of the  Method Support the Applicability  of the SMPR?  If not, please explain  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). what is missing.

No. This method didn't demonstrate its capability to separate and quantify beta‐ cryptoxanthin isomers, lutein and zeaxanthin.

Yes

No. In this method, it specified dietary supplements in beadlets form.

No. Suggested wording: In this method, various organic solvents (hexanes,  chloroform, etc.,) along with several other hazardous chemicals are used and special  care should be taken when handling or disposing of these chemicals. Wear gloves,  safety glasses and use in a fume hood. Follow all laboratory safety precautions. Refer  to Safety Data Sheets (SDS) for any questions relating to any chemicals in use.

1.  Are the definitions specified in  No. Reproducibility was replaced by word "ruggedness", which is a completely  III.  Review of Information in Support of the Method the SMPR used and applied  different property of a method.

appropriately in the supporting  documentation (manuscripts,  method studies, etc…)?  If not,  please explain the differences and  if the method is impacted by the  difference.