the Stakeholder Panel on Dietary Supplements

50 51 52 53 54 55 56 57 58 59 60 61 62

Recovery .— The fraction or percentage of spiked analyte that is recovered when the test

sample is analyzed using the entire method.

SAM-e – S -Adenosyl methionine, IUPAC name: (2 S )-2-Amino-4-[[(2 S ,3 S ,4 R ,5 R )-5-(6- aminopurin-9-yl)-3,4-dihydroxyoxolan-2-yl] methyl-methylsulfonio]butanoate. CAS number:

97540-22-2.

5. Method Performance Requirements :

Table 1: Analytical Range & LOQ Based on Matrix

Parameter Analytical range (mg/g)

≤ 5 to ≤ 800

LOQ mg/g)

1

Note: Results are in Total SAMe 63 64 65 Table 2: Method Performance Requirements as a Function of Range

66 67

Range

Parameter

≤ 15 mg/g

> 15 mg/g

Recovery (%)

≥ 90

≥ 98

% RSD r

≤ 8

≤ 5

% RSD R

≤ 10

≤ 8

68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85

Note: Results are in Total SAMe

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.

7. Reference Material(s):

USP Ademetionine Disulfate Tosylate (S-Adenosyl-L-Methionine Disulfate Tosylate;

Catalog no. 1012134.

Sigma (detail to be added)

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