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Quantitative method
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Method of analysis which response is the amount of the analyte measured either directly
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(enumeration in a mass or a volume), or indirectly (color, absorbance, impedance, etc.) in a certain
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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
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instrument and operator and repeating during a short time period. Expressed as the repeatability
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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.
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Expressed as the reproducibility relative standard deviation (SD
R
); or % reproducibility relative
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standard deviation (% RSD
R
).
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Recovery
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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
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for Standard Method Performance Requirements
, 19
th
Edition of the AOAC INTERNATIONAL Official
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Methods of Analysis (2012). Available at:
http://www.eoma.aoac.org/app_f.pdf77
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NIST Guidance document
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Withanoside IV
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Withanoside V
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Withaferin A
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Withanolide A
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Withanolide B
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Withastramonolide
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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
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at:
http://www.eoma.aoac.org/app_d.pdf95
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