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Quantitative method

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Method of analysis which response is the amount of the analyte measured either directly

49

(enumeration in a mass or a volume), or indirectly (color, absorbance, impedance, etc.) in a certain

50

amount of sample.

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Repeatability

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Variation arising when all efforts are made to keep conditions constant by using the same

54

instrument and operator and repeating during a short time period. Expressed as the repeatability

55

standard deviation (SD

r

); or % repeatability relative standard deviation (%RSD

r

).

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Reproducibility

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The standard deviation or relative standard deviation calculated from among-laboratory data.

59

Expressed as the reproducibility relative standard deviation (SD

R

); or % reproducibility relative

60

standard deviation (% RSD

R

).

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Recovery

63

The fraction or percentage of spiked analyte that is recovered when the test sample is analyzed

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using the entire method.

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5.

Method Performance Requirements

:

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See table 1 and 2.

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6.

System suitability tests and/or analytical quality control:

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Suitable methods will include blank check samples, and check standards at the lowest point and

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midrange point of the analytical range.

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7.

Reference Material(s):

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Refer to Annex F:

Development and Use of In-House Reference Materials

in

Appendix F :

Guidelines

75

for Standard Method Performance Requirements

, 19

th

Edition of the AOAC INTERNATIONAL Official

76

Methods of Analysis (2012). Available at:

http://www.eoma.aoac.org/app_f.pdf

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NIST Guidance document

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Withanoside IV

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Withanoside V

82

Withaferin A

83

Withanolide A

84

Withanolide B

85

Withastramonolide

86

Withanone

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8.

Validation Guidance

:

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All target compounds in table 3 and all matrices in table 4 shall be evaluated.

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Appendix D :

Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method

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of Analysis;

19

th

Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available

94

at:

http://www.eoma.aoac.org/app_d.pdf

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