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Submission Date

2016-07-28 12:47:46

Name

Martha Jennens

E-mail

martha.jennens@covance.com

Organization

Covance

Title of Method

Determination of Catechins and Caffeine in Camillia sinensis Raw Materials, Extracts

and Dietary Supplements by HPLC-UV: Single Laboratory Validation

AOAC Candidate Method

Number (e.g. ALN-01)

TEA-02

Applicable SMPR

2015.014

Summary:

A rapid method to quantify seven catechins and caffeine in green tea raw material and

powdered extract and dietary supplements containing green tea extract. The method

utilizes RP HPLC with a phenyl column and gradient elution with UV detection and a 13

minute run time.

1. Does the applicability of

the method support the

applicability of the SMPR? If

not, please explain what is

missing.

No. The method only applies to seven of eight catechins, one of three methyl

xanthines (caffeine) and no theaflavin or theanine is covered.

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, but it does not cover all analytes in the SMPR.

3. Are the definitions

specified in the SMPR used

and applied appropriately 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 reagents,

components, instrumentation,

or method steps that may be

hazardous? If no, please

suggest wording or option(s).

There is no discussion in the method around safety/precautions in use of chemicals,

etc.

AOAC SPDS ERP - Set 3 Review Form 2