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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