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Name of the ingredient
Chicken comb extract
Definition of the ingredient
The substance is extracted from Chicken comb (Gallus gallus or rooster comb) by mild enzymatic hydrolysis followed by filtration, concentration and precipitation. Chicken combs are collected from poultry that are fit for human consumption.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | White or almost white hygroscopic powder |
| Characteristics | ||
| pH | Ph. Eur. 2.2.3 | 5.0 – 8.5 |
| Loss on drying | Ph. Eur. 2.2.32 | Not more than 10% |
| Nitrogen | Ph. Eur. 2.5.9 | Not more than 8% |
| Chloride | Ph. Eur. 2.4.4 | Not more than 1% |
| Identification | ||
| FT-IR (Sodium hyaluronate) | Ph. Eur. 2.2.24. | Complies with Ph. Eur. Reference spectrum of sodium hyaluronate |
| Sodium Hyaluronate | Ph. Eur. 1472 | pink colour solution |
| Chondroitin Sulphate A and Dermatan Sulphate (Chondroitin Sulphate B) | Capillary electrophoresis | Retention time should be consistent with the reference standard of Dermatan. |
| Assay | ||
| Sodium Hyaluronate | Ph. Eur. 1472 | 60-75% |
| Test | Method reference | Acceptance criteria |
| Chondroitin Sulphate A and Dermatan Sulphate (Chondroitin Sulphate B) | Capillary electrophoresis (Malavaki et al., 2008) Ph. Eur. 2.2.47 |
≤ 25% |
| Protein | Ph. Eur. Method 2.5.33 (Appendix VIII P. Total Protein) |
10-25% |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Methanol | Ph. Eur. method 2.4.24 (Gas chromatography (Ph. Eur. Method 2.2.28) with appropriate validated method) |
Complies |
| Ethanol | Ph. Eur. method 2.4.24 (Gas chromatography (Ph. Eur. Method 2.2.28) with appropriate validated method) |
Complies |
| Acetone | Ph. Eur. method 2.4.24 (Gas chromatography (Ph. Eur. Method 2.2.28) with appropriate validated method) |
Complies |
| Incidental metals and non-metals | ||
| While ingredient manufacturers are encouraged to include limits for incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, which must comply with the acceptance criteria set in the United States Pharmacopoeia – National Formulary (USP-NF) general chapter '<2232> Elemental Contaminants in Dietary Supplements'. | ||
| Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) | ||
| Test | Method reference | Acceptance criteria |
| Pesticides | Ph. Eur. method 2.8.13 | complies |
| Antibiotic residues | LC MS/MS | Complies with Australia New Zealand Food Standards Code, Standard 1.4.2 (Schedule 20 – maximum residue limits for chicken meat) |
| Other organic or inorganic impurities or toxins | ||
| Dioxins | EPA method 1613 | Not more than 2.0 pg/g |
| Dioxins and PCBs | EPA method 1613 | Not more than 4.0 pg/g |
| 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 that 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
BP = British Pharmacopoeia
HPLC = High performance liquid chromatography
IR = Infrared
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia
pg = picogram
LC MS/MS = Liquid chromatography coupled with 2 mass analysers