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Compositional guideline: Zeaxanthin

17 November 2011

Name of the ingredient

Zeaxanthin (AAN)

Definition of the ingredient

Zeaxanthin is (3R, 3'R)-dihydroxy-β-carotene.

It is obtained by chemical synthesis.

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Orange-red crystalline powder
Colour and clarity of solution 0.05% w/v in chloroform Clear, orange-red solution
Characteristics
Loss on drying BP (Appendix IX D); determined by drying 1.000 g in vacuo at 80°C for 18 hr ≤ 0.2%
Identification
Test A TLC Complies with a reference standard
Test B HPLC Complies with a reference standard
Assay
Content of trans zeaxanthin* HPLC 96.0 - 101.0%
Isomeric purity of trans zeaxanthin:
(3R, 3'R)-zeaxanthin
HPLC ≥ 98.0%
Notes: *Trans zeaxanthin is a mixture of (3R, 3'R)-zeaxanthin, (3S, 3'S)-zeaxanthin, and (3R, 3'S)-(3S,3'R)-mesozeaxanthin.
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Residual solvents
Residual solvents BP Complies
Incidental metals and non-metals
Cadmium AA ≤ 1 ppm
Mercury AA ≤ 1 ppm
Arsenic AA ≤ 1 ppm
Lead AA ≤ 5 ppm
Nickel AA ≤ 10 ppm
Palladium AA ≤ 10 ppm
Other organic or inorganic impurities or toxins
Related substances
Cis-isomers of zeaxanthin HPLC ≤ 2.0%
C25–zeanylaldehyde HPLC ≤ 0.1%
7',8'-dihydrozeaxanthin HPLC ≤ 0.1%
7',8'-didehydrozeaxanthin HPLC ≤ 0.1%
Triphenylphosphine oxide HPLC ≤ 10 ppm
Sulfated ash BP (Appendix IX A) ≤ 0.1%
Peroxide value BP (Appendix X F) ≤ 5
Microbiology While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product which contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order.

Key to abbreviations:

AA = Atomic absorption

BP = British Pharmacopoeia

HPLC = high-pressure liquid chromatography

Ph Eur = European Pharmacopoeia

TLC = Thin layer chromatography