SPDS Lutein and Turmeric ERPs

Reviewer Name:

Holly Johnson

Email:

holly@alkemist.com

Organization:

Alkemist Labs

Method Reviewed:

TUR‐01

Method Title:

Curcuminoids in Turmeric Roots and Supplements: Method Optimization and

Validation

Applicable SMPR

2016.003

Summary of Method:

Presented is a validated HPLC‐UV method for quantitation of individual curcuminoids

in turmeric raw materials and finished products. Method parameters were modified

in response to a previous ERP; extraction and separation have been optimized, with

extraction solvent and column temp being significant factors. Factorial studies were

used to guide optimization and a Single Lab Validation was performed on 12

materials with the modified method.

1. Does the Applicability of the

Method Support the Applicability

of the SMPR? If not, please explain

what is missing.

Yes

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.

Yes

3. Are the definitions specified in

the SMPR used and applied

appropriatly in the method? If no,

please indicate how the terms are

used.

Yes

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).

N/A

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.

Yes

I. Summary

II. Review of the Method Only

III. Review of Information in Support of the Method

General Information