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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

2

Method Safety Concerns: Safe

handling of the chemicals involved listed

Pros/Strengths:

Quite sensitive method

The method lists steps to establish purity of standards.

Cons/Weaknesses

Involves hot saponification

Not able to distinctly separate previtamin D from vitamin D

Supporting Data

General Comment: Required data are available

Method Optimization: Data not provided

Performance Characteristics:

Analytical Range:

The average range for vitamin D

2

concentration of 0.04–7.3 μg hg

-1

RTF which extends

beyond limits of the range specified in the vitamin D SMPR.

The average range for vitamin D

3

0.06–11.3 μg hg

-1

RTF which exceeds the range specified

in the vitamin D SMPR.

LOQ:

The LOQ for vitamin D

2 =

0.016 μg hg

-1

.

The LOQ for vitamin D3 = 0.028 μg hg

-1

.

LOQ for both vitamin D

2

and vitamin D

3

are lower than those defined in the vitamin D

SMPR.

VitD-18 Review Forms