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.
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