15 / 65
FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
3
0.07 m/L * 0.05 L * 100 * 1000 = 0.0175 mg/100g powder/Liquid
2 (g/mL) * 1000
Accuracy/Recovery:
93.8 – 104.9 %
SRM 181.3 mg/100g vs Ref value of184 mg/100g – 98.5 % recovery
Precision (RSD
r
):
5.0 – 50 mg/100g
≤ 0.2 – 2.0% except HA with soy at 5 %
50 – 2500 mg/100g
≤ 0.3 – 1.9 %
Intermediated Precision:
5.0 – 50 mg/100g
≤ 1.0 – 2.4% except HA with soy at 6.9 %
50 – 2500 mg/100g
≤ 1.9 – 3.7 %
System suitability:
Method didn’t mention system suitability
Only enzyme blank included – recommend more are added
Recommendation:
1.
5-M-trp as the internal standard added before hydrolysis is not necessary, since it didn’t monitor the
enzymatic hydrolysis loss. If weighing and dilutions are performed accurately (analytical balance and
volumetric flask), the internal standard can be added late or not needed at all.
2.
The performance of this method is very good (precision and accuracy) in most of matrices except a
little out of SMPR for soy hydrolyzed infant formula product (precision).
3.
The design of spike-recovery is very reasonable, both using BSA to the samples matrices and comparing
to SRM 1849a and SRM927e (BSA). The recovery for BSA demonstrates the accuracy better than
SRM1849a, since the content of tryptophan in BSA is decided by the amino acid profile of the protein.
4.
Recommend for First Action and MLT Study
.