Stakeholder Panel Meeting Book - September 6, 2014

Reproducibility

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The standard deviation or relative standard deviation calculated from among- laboratory data. Expressed as the reproducibility relative standard deviation (SD R ); or % reproducibility relative standard deviation (% RSD R ).

4. Method Performance Requirements:

Analytical range

5 - 200*

Limit of Quantitation (LOQ)

≤ 5 *

5-25

80-120%

Recovery

26-200

90-110%

5-25

≤ 8%

Repeatability (RSD r )

26-200

≤ 5%

5-25

≤ 15%

Reproducibility (RSD R )

26-200

≤ 10%

Concentrations apply to: a) ‘ready -to- feed” liquids “as is”; b) re - constituted powders (25 g into 200 g of deionized water); and c) liquid concentrates diluted 1:1 by weight with deionized water.

* μ g /100 g reconstituted final product. 60 61 5. System suitability tests and/or analytical quality control: 62

Suitable methods will include blank check samples, and check standards at the 64 65 6. Reference Material(s) : Neither NIST nor IRRM produce an CRM for fluoride in infant 66 formula. The fluoride content of SRM 1849a has not been determined (as of 67 11/20/2013). 63 lowest point and midrange point of the analytical range.

68 69 70 71 72 73 74

7. Validation Guidance :

Recommended level of validation: Official Methods of Analysis SM .

8. Maximum Time-To-Result : No maximum time.