2
repeatability standard deviation (SD
r
); or % repeatability relative standard deviation
48
(%RSD
r
).
49
50
Reproducibility
51
The standard deviation or relative standard deviation calculated from among-laboratory
52
data. Expressed as the reproducibility relative standard deviation (SD
R
); or % reproducibility
53
relative standard deviation (% RSD
R
).
54
55
Vitamin B
6
(Pyridoxine)
56
All 2-methyl-3-hydroxy-5-hydroxy methyl pyridine compounds with equivalent biological
57
activity of pyridoxine (PN)(2-methyl-3-hydroxy-4,5-bis(hydroxymethyl)-pyridine in rats. See
58
figure 1. CAS registry number for pyridoxine
59
60
61
4.
Method Performance Requirements:
62
63
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.
*μg /100 g reconstituted final product.
64
65
66
5.
System suitability tests and/or analytical quality control:
67
Suitable methods will include blank check samples, and check standards at the lowest point
68
and midrange point of the analytical range.
69
70
6. Reference Material(s):
71
NIST Standard Reference Material
®
1849a; Infant/Adult Nutritional Formula or equivalent.
72
The SRM is a milk-based, hybrid infant/adult nutritional powder prepared by a manufacturer
73
of infant formula and adult nutritional products. A unit of SRM 1849 consists of 10 packets,
74
each containing approximately 10 g of material. Certified value of NIST1849a is 13.46
±
0.93
75
mg/Kg of vitamin B
6
(pyridoxine).
76
77
7. Validation Guidance
:
78
Recommended level of validation:
Official Methods of Analysis
SM
.
79
80
8. Maximum Time-To-Result
: No maximum time.
81
82
