2018 March 16 SPDS

51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73

Repeatability .— Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator and repeating during a short time period.

Expressed as the repeatability standard deviation (SD r

); or % repeatability relative standard

deviation (%RSD r ).

Reproducibility .— The standard deviation or relative standard deviation calculated from among-laboratory data. Expressed as the reproducibility relative standard deviation (SD R );

or % reproducibility relative standard deviation (% RSD R ).

Recovery .— The fraction or percentage of spiked analyte that is recovered when the test

sample is analyzed using the entire method.

Trans Resveratrol.- IUPAC name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol. CAS

number: 501-36-0. See figure 1 for chemical structure.

Analytical range – Includes all steps of the analytical procedure including sample

preparation and further dilutions.

5. Method Performance Requirements :

Table 2: Analytical Range & LOQ Based on Matrix

Parameter Analytical range (% w/w)

0.05 - 100

Limit of Quantitation (% w/w)

0.01

74 75 76 77

Range may be narrower depending on the analytical matrix.

Table 3: Method Performance Requirements as a Function of Range

Parameter

Acceptance Criteria

1-50%

50-100%

< 1%

98 - 102

97 - 103

% Recovery

85 - 115

5.3

2

% RSD r

≤ 7.5

≤ 8

3

% RSD R

≤ 10

78 79 80 81 82 83 84

6. System suitability tests and/or analytical quality control:

Suitable methods will include blank check samples, and check standards at the lowest point and midrange point of the analytical range. A control sample must be included. The

method must be specific for trans resveratrol.