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Compositional guideline: Chicken comb extract

18 January 2018

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.

Table 1: Ingredient specific requirements
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%
Table 2: Incidental constituents
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