MCPD-02 Reviewer Forms (July 19, 2018)

FOR EXPERT REVIEW PANEL USE ONLY NOT FOR DISTRIBUTION

Reviewer 4

Method clarity has improved with revision.

Method Safety Concerns:

Safety is addressed in the document (cover page for general handling of chemicals, D(1)b for extraction under pressure).

Pros/Strengths: • Answer SMPR requirements • Internal standards added early in extraction steps to control all analytical steps

Cons/Weaknesses •

Supporting Data • General Comment:

Extensive data collection to support SLV

- Method Optimization:

• Performance Characteristics:

All performances characteristics below meet SMPR:

Analytical Range LOQ Accuracy/Recovery Precision (RSD r ) Reproducibility (RSD R )

• System suitability: System suitability has been added according to recommendations.

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