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.