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Acceptance Criteria
The standard method performance requirements (SMPR 2014.013) are summarized in the table below.
Results
Precision
Repeatability requirements were met for all SPIFAN matrices with the exception of the partially
hydrolyzed soy-based powder lot 410457651Z at 5.0%. This sample also showed clumping in the
reconstitution. Other Repeatability results ranged from 0.2-2.0% RSD. The overall average RSD
r
was 1.0%
and RSD
iR
2.3%. See precision table attached.
Accuracy
Spike recovery requirements were met for all SPIFAN matrices. Mean spike recovery data ranged from
93.8-104.9%. See attached accuracy table. The SRM 1849a mean result of 181.3 mg/100g is 98.5% of
the 184 mg/100g reference value.
Linearity
The method demonstrated good linearity over a standard range of ~0.2-30 mg/L Tryptophan with eight
dilution levels having average percent deviation from theoretical value of 0.3%. No single point in the
experiments exceeded 4.5% deviation from theoretical. See TABLE 3 Linearity Data.
Table 2. Method performance requirements
a
Parameter
Analytical range
Limit of quantitation (LOQ)
0.4–5.0
b
±10%
5.0–50
±8%
50–2500
±5%
0.4–5.0
a
≤4%
5.0–50
≤3%
50–2500
≤2%
0.4–5.0
b
≤6%
5.0–50
≤4%
50–2500
≤3%
0.4–2500
b
≤0.4
b
a
Concentrations apply to: (a) ‘ready-to-feed” liquids “as is”; (b)
reconstituted powders (25 g into 200 g water); and (c) liquid concentrates
diluted 1:1 by weight using water.
b
mg/100 g reconstituted final product.
Recovery
Repeatability (RSD
r
)
Reproducibility (RSD
R
)
Minimum acceptable criteria
AMINO-02 (FEBRUARY 2017)
SLV - FINAL REPORT
FOR ERP USE ONLY
DO NOT DISTRIBUTE
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