Review Team (February 2016)

BVit-03 (February 2016) FOR ERP USE ONLY DO NOT DISTRIBUTE

Table : Validation parameters and Acceptance Criteria for B- Vitamins Validation Parameter Criteria

Parameter

Acceptance Criteria

R2

≥ 0.99 For ≤ 10 μg/l : 70-125 % 10-1000 μg/l : 75-120 %

Linearity/Calibration fit

Back calculated values accuracy

Accuracy

70 - 125 %

LOQ

Precision (RSD %)

≤ 15 %

Ion Ratio

Least/Most intesne ion ratio

Maximum tolerance (relative)

0.50 - 1.00 0.20 - 0.50 0.10 - 0.20

± 30 % ± 30 % ± 30 % ± 30 %

Specificity

<0.10

RT ratio

0.95 - 1.05

Concentration ≤ 10 μg/kg 1.0 mg/kg 10 mg/kg 0.01 g/100g 0.1 g/100g 1.0 g/100g 10 g/100g 100 g/100g ≤ 10 μg/kg 1.0 mg/kg 10 mg/kg 0.01 g/100g 0.1 g/100g 1.0 g/100g 10 g/100g 100 g/100g ≤ 10 μg/kg 1.0 mg/kg 10 mg/kg 0.01 g/100g 0.1 g/100g 1.0 g/100g 10 g/100g 100 g/100g Concentration Concentration

Recovery limits, %

70 - 125 75 - 120 80 - 115 85 - 110 90 - 108 92 - 105 95 - 102 98 - 101

Accuracy

Repeatability (RSDr), %

15

8 6 4 3 2

Repeatability Precision (RSDr)

1.5

1

Repeatability (RSD R ), %

32 16 11

Reproducibility Precision (RSD R )

8 3 2

1.5

1

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