Stakeholder Panel Meeting Book - September 6, 2014

Range mg/100g

RSD

RSD

Recovery

r

R

0.4 -5.0

<4%

<6%

90-110%

5.0 - 50

<3%

<4%

92-108%

50 -2500

<2%

<3%

95-105%

65 66 67

5. Method Performance Requirements: -Taurine

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 69 70 71 72

*mg /100 g reconstituted final product.

Target Measurement Uncertainty (TMU) - Taurine

The maximum measurement uncertainty that will satisfy the intended use of a given

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 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). 76

83 84 85 86 87 88 89 90

7. Validation Guidance :

Recommended level of validation: Official Methods of Analysis SM .

8. Maximum Time-To-Result : No maximum time.

4 See VIM definition 2.34 for formal definition. Calculated as: TMU = √ RSD R 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. 2 + RSD r 2 + U s