Range
mg/100g
RSD
r
RSD
R
Recovery
0.4 -5.0
<4%
<6%
90-110%
5.0 - 50
<3%
<4%
92-108%
50 -2500
<2%
<3%
95-105%
65
5.
Method Performance Requirements: -Taurine
66
67
Analytical range
2
–
70*
Limit of Quantitation (LOQ)
≤
2
*
Accuracy
± 10%
Repeatability (RSD
r
)
≤
8%
Reproducibility (RSD
R
)
≤
11%
Target Measurement Uncertainty
≤
14.5%
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.
68
*mg /100 g reconstituted final product.
69
70
Target Measurement Uncertainty (TMU) - Taurine
71
The maximum measurement uncertainty that will satisfy the intended use of a given
72
method.
4
73
74
6.
System suitability tests and/or analytical quality control:
75
Suitable methods will include blank check samples, and check standards at the
76
lowest point and midrange point of the analytical range.
77
78
6.
Reference Material(s):
NIST Standard Reference Material
®
1849a; Infant/Adult
79
Nutritional Formula - or equivalent. SRM 1849a is a milk-based, hybrid infant/adult
80
nutritional powder. One unit of SRM 1849a contains 10 packets each containing
81
approximately 10 g of material. The certified value of NIST SRM1849a for amino acids is
82
xxxxx and taurine is 0.035 ± 0.007% (35 ± 7 mg/100g).
83
84
85
7.
Validation Guidance
:
86
Recommended level of validation:
Official Methods of Analysis
SM
.
87
88
8.
Maximum Time-To-Result
: No maximum time.
89
90
4
See VIM definition 2.34 for formal definition. Calculated as: TMU =
√
RSD
R
2
+ RSD
r
2
+ U
s
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.
