SPDS Meeting Book

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

Made with