Name of the ingredient
Zeaxanthin (AAN)
Definition of the ingredient
Zeaxanthin is (3R, 3'R)-dihydroxy-β-carotene.
It is obtained by chemical synthesis.
| 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. | ||
| 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
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