SPDS Meeting Book
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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.
4. Method Performance Requirements :
5. METHOD PERFORMANCE REQUIREMENTS :
Table 1a: Analytical Ranges and LOQ for Aloin A or B
Finished Products
Raw Material
Analytical range (ppm)
0.01 to 100
0.01 to 12,500
LOQ (ppm)
0.005
0.005
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Table 1b: Performance Parameters for Aloin A or B
ranges (ppm) finished product and raw ingredients
raw ingredients
Parameter
>100 – 1000
>1000- 12,500
0.01 – 1
>1 – 10
>10 – 30
>30 – 100
% Repeatability (RSD r )
21
11
7
6
5
3
Recovery (%)
60-115
80-110
90-107
95-105
% Reproducibility (RSD R )
32
16
11
9
7
4
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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. 76 77 6. Reference Material(s): Refer to Annex F of Appendix F in OMA. Refer to 19 th Edition of the 78 AOAC INTERNATIONAL Official Methods of Analysis (2012). Annex F : Development and Use 79 of In-House Reference Materials in Appendix F : Guidelines for Standard Method Performance 80 Requirements. Available at: http://www.eoma.aoac.org/app_f.pdf
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7. Validation Guidance :
Recommended level of validation: Official Methods of Analysis SM
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