AOAC SPDS Mid Year 2016

DRAFT AOAC SMPR 2016.XXX; Version 4; November 19, 2015 1 2 SMPR Name: 3

Quantitative measurement of β-cryptoxanthin, lutein, and zeaxanthin in ingredients and dietary supplements.

4 5 Intended Use : Reference method for cGMP compliance.

6 7

1. Purpose 8 9 AOAC SMPRs describe the minimum recommended performance characteristics to be used during 10 the evaluation of a method. The evaluation may be an on-site verification, a single-laboratory 11 validation, or a multi-site collaborative study. SMPRs are written and adopted by AOAC Stakeholder 12 Panels composed of representatives from the industry, regulatory organizations, contract 13 laboratories, test kit manufacturers, and academic institutions. AOAC SMPRs are used by AOAC 14 Expert Review Panels in their evaluation of validation study data for method being considered for 15 Performance Tested Methods or AOAC Official Methods of Analysis , and can be used as acceptance 16 criteria for verification at user laboratories. [Refer to Appendix F: Guidelines for Standard Method 17 Performance Requirements , Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., 18 AOAC INTERNATIONAL, Gaithersburg, MD, USA.]

19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49

2. Applicability :

Separate quantitative determination of β-cryptoxanthin, lutein, and zeaxanthin in ingredients and

dietary supplements.

3. Analytical Technique :

Any analytical technique(s) that measures the analytes of interest and meets the following method

performance requirements is/are acceptable.

4. Definitions :

Analytes

β-Cryptoxanthin

IUPAC name: (R)-3,5,5-Trimethyl-4-[3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohex-1-enyl)- octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-cyclohex-3-enol. CAS registry number: 472-70-8. See

figure 1 for chemical structure.

Lutein

IUPAC name: β,ε-carotene-3,3'-diol. CAS registry number 1 27-40-2. See figure 2 for chemical

structure.

Zeaxanthin

IUPAC name: 4-[18-(4-hydroxy-2,6,6-trimethyl-1-cyclohexenyl)-3,7,12,16-tetramethyl-octadeca- 1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethyl-cyclohex-3-en-1-ol. CAS registry number: 144-

68-3. See figure 3 for chemical structure.