SPDS Meeting Book

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

Ranges (µg/g)* 

Parameter 

< 10 ‐ 15 

>15 ‐ 50 

>50 – 500 

>500 – 4,000 

>4000 – 12,500 

Recovery (%)  % R t bilit  epea a y  (RSD r )  % Reproducibility  (RSD R ) 

80 ‐ 110 

90 ‐ 107 

95 – 105 

95 – 105 

97 – 103 

8 

7 

5 

4 

3 

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?