Vitamin D SMPR Revision

7 Validation Guidance Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis , Official Methods of Analysis (current edition), AOAC INTERNATIONAL, Rockville, MD, USA. Available at: http://www.eoma.aoac.org/ app_d.pdf Appendix K: Guidelines for Dietary Supplements and Botanicals , Official Methods of Analysis (current edition), AOAC INTERNATIONAL, Rockville, MD, USA (http://www.eoma. aoac.org/app_k.pdf). Also at: J. AOAC Int. 95 , 268(2012); DOI: 10.5740/jaoacint.11-447 8 Maximum Time-to-Determination No maximum time. Approved by AOAC Stakeholder Panel on Dietary Supplements (SPDS). Final Version Date: September 25, 2015. Effective Date: September 25, 2015.

Table 1.  Analytical range and LOQ based on matrix Parameter

Finished products Ingredients

Analytical range ppm a Limit of quantitation ppm a

0.5–12500

1250–12500

0.4 1000 a  Measured as individual forms of vitamin D and pre-vitamin D.

Table 2. Method performance requirements as a function of range

Range, µg/g a

Parameter

<10–15 80–110

>15–50 90–107

>50–500 95–105

>500–4000

>4000–12500

Recovery, %

95–105

97–103

Repeatability (RSD r Reproducibility (RSD R ), %

8

7

5 8

4 6

3 4

), %

12

10

a  Measured as individual forms of vitamin D and pre-vitamin D.

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