Standard Format for AOAC Standard Method Performance Require

51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66

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

67 68 69

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

70 71 72 73 74 75

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

81 82 83 84

7. Validation Guidance :

Recommended level of validation: Official Methods of Analysis SM