SPDS Draft SMPR - Free Amino Acid v6.1.docx

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Repeatability  

Variation arising when all efforts are made to keep conditions constant by using the same  instrument and operator and repeating during a short time period. Expressed as the 

repeatability standard deviation (SD r

); or % repeatability relative standard deviation 

(%RSD r

). 

Reproducibility 

The standard deviation or relative standard deviation calculated from among‐laboratory 

data. Expressed as the reproducibilitystandard deviation (SD R

); or % reproducibilityrelative 

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. 

5. Method Performance Requirements :   

See table 3 and 4. 

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. 

7. Potential Reference Material(s):

Refer to Annex F: Development and Use of In‐House Reference Materials  in Appendix F:  Guidelines for Standard Method Performance Requirements , 19 th  Edition of the AOAC  INTERNATIONAL Official Methods of Analysis (2012).  Available at:  

http://www.eoma.aoac.org/app_f.pdf 

8. Validation Guidance : 

Data must demonstrate ability to identify and quantitate the free amino acids in Table 1 in  the presence of the non‐target compounds in Table 5.  Interferences with the identification  and quantitation of target compounds should be reported in the method.  Method developers should be able to demonstrate that candidate methods can in fact  identify and quantitate minor target compounds in the presence of greater concentrations 

of other amino acids and their related compounds. 

Appendix D: Guidelines for Collaborative Study Procedures To Validate Characteristics of a  Method of Analysis; 19 th  Edition of the AOAC INTERNATIONAL Official Methods of Analysis 

(2012).  Available at:  http://www.eoma.aoac.org/app_d.pdf 

Appendix F:  Guidelines for Standard Method Performance Requirements; 19 th Edition of the  AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at:  

http://www.eoma.aoac.org/app_f.pdf 

Appendix K : Guidelines for Dietary Supplements and Botanicals, Official Methods of Analysis 

(2016) 20th Ed., AOAC INTERNATIONAL.