Stakeholder Panel Meeting Book - September 6, 2014

Expressed as the repeatability standard deviation (SD r ); or % repeatability

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relative standard deviation (%RSD r ).

Reproducibility

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 ).

Target Measurement Uncertainty (TMU)

The maximum measurement uncertainty that will satisfy the intended use of a given

method. 4

4. Method Performance Requirements:

Analytical range

5 - 500*

Limit of Quantitation (LOQ)

≤ 5 *

Accuracy

95-105%

Repeatability (RSD r )

≤ 2%

Reproducibility (RSD R )

≤ 4%

Concentrations apply to: a) ‘ready -to- feed” liquids “as is”; b) re - constituted powders (25 g into 200 g of water); and c) liquid concentrates diluted 1:1 by weight using water. * mg /100 g reconstituted final product. 65 66 5. System suitability tests and/or analytical quality control: 67

Suitable methods will include blank check samples, and check standards at the 69 70 6. Reference Material(s): NIST Standard Reference Material ® 1849a; Infant/Adult 71 Nutritional Formula - or equivalent. SRM 1849a is a milk-based, hybrid infant/adult 72 nutritional powder. One unit of SRM 1849a contains 10 packets each containing 73 approximately 10 g of material. The reference value of NIST SRM 1849a for chlorine is: 74 7010 mg/kg. 68 lowest point and midrange point of the analytical range.

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7. Validation Guidance :

Recommended level of validation: Official Methods of Analysis SM .

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

4 See VIM definition 2.34 for formal definition. Calculated as: TMU = √ RSD R 2, where RSD R = the relative standard deviation of reproducibility; RSD r = the relative standard deviation of repeatability; and U s = the uncertainty of the sample. 2 + RSD r 2 + U s

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