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SMPR Key Points
1.
Method Performance Requirements
:
Table 1: Analytical Range & LOQ Based on Matrix
Parameter
Finished Products
Raw Materials
Analytical range ppm*
0.5 – 338
1,250 ‐ 12,500
Limit of Quantitation ppm*
0.4
1,000
Table 2: Method Performance Requirements as a Function of Range
Parameter
Ranges (µg/g)*
< 10 ‐ 15
>15 ‐ 50
>50 – 500
>500 – 4,000
>4000 – 12,500
Recovery (%)
80 ‐ 110
90 ‐ 107
95 – 105
95 – 105
97 – 103
% R t bilit
epea a y
(RSD
r
)
8
7
5
4
3
% Reproducibility
(RSD
R
)
12
10
8
6
4
* Measured as individual forms of Vitamin D and pre‐Vitamin D
Comments Submitted (if any)
•
One Comment Submitted
–
“The two certified reference materials I
mentioned were vitamin D2 and vitamin D3.
We have other vitamin D standards in the
attached but they are the metabolites.”
•
Cerilliant Vitamin D2V‐024 Vitamin D3V‐025
–
1 mg/ml CRM in Ethanol
St k h ld D dd t SMPR
–
a e o ers: o we a o
as a
requirement to use?