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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