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ANTH-003

Pros/Strengths

1. Chromatography is impressive. The usability of LC with

DAD, MS, or both detection technologies allows

confirmations to occur.

2. Extraction protocol is very simple.

Cons/Weaknesses

1. No work was reported on the method being able to

evaluate the presence of fruits listed in Annex II,

Exclusivity Panel; Selected Non-Vaccinium Fruit.

2. Only one of the seven types of sample matrices was

studied. While I do expect the method to properly

analyze the remaining matrix types, I believe this must be

first demonstrated.

3. Some peaks were not fully characterized but were

"noted as to their type based on MRM information". The

author did mention additional testing on a newer

instrument would likely identify the unidentified peaks.

Supporting Data

General Comments

Chromatograms show acceptable separation of targeted

compounds.

Method Optimization

No study was performed on evaluating if the method can

correctly identify all of the authenticity panel (Annex i)

materials in the presence or absence of fruits listed in the

exclusivity panel (Annex II)

Performance Characteristics

Analytical Range:

Standard calibration curve: 18 to 180 mg/L cyanidin-3-

chloride

LOQ:

N/A for this qualitative method

Accuracy/Recovery

N/A for this qualitative method

Precision (RSDr)

N/A for this qualitative method

Reproducibility (RSDR)

N/A for this qualitative method

System Suitability

No study was performed on evaluating if the method can

correctly identify all of the authenticity panel (Annex i)

materials in the presence or absence of fruits listed in the

exclusivity panel (Annex II)

Safety Review

Is the method safe to use as written?

No specific usage or safety practices listed

Are there any safety concerns with

any component, instrument, reagent

or instruction of the method? If yes,

None were evident outside of handling acids