Stakeholder Panel Meeting Book - September 6, 2014
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repeatability standard deviation (SD r
); or % repeatability 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 ).
Vitamin B 6
(Pyridoxine)
All 2-methyl-3-hydroxy-5-hydroxy methyl pyridine compounds with equivalent biological activity of pyridoxine (PN)(2-methyl-3-hydroxy-4,5-bis(hydroxymethyl)-pyridine in rats. See
figure 1. CAS registry number for pyridoxine: 65-23-6.
4. Method Performance Requirements:
Analytical range
20 – 250*
Limit of Quantitation (LOQ)
≤ 20*
Accuracy
± 20%
Repeatability (RSD r )
≤ 14%
Reproducibility (RSD R )
≤ 20%
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.
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*μg /100 g reconstituted final product.
5. System suitability tests and/or analytical quality control:
Suitable methods will include blank check samples, and check standards at the lowest point
and midrange point of the analytical range.
6. Reference Material(s):
NIST Standard Reference Material ® 1849a; Infant/Adult Nutritional Formula or equivalent. The SRM is a milk-based, hybrid infant/adult nutritional powder prepared by a manufacturer of infant formula and adult nutritional products. A unit of SRM 1849 consists of 10 packets,
each containing approximately 10 g of material. Certified value of NIST1849a is 13.46 ± 0.93
mg/Kg of vitamin B 6
(pyridoxine).
7. Validation Guidance :
Recommended level of validation: Official Methods of Analysis SM .
8. Maximum Time-To-Result : No maximum time.
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