Hydrolysed Chicken Cartilage Extract
Compositional guideline for 'Hydrolysed Chicken Cartilage Extract' permitted for use in listed medicines
Name of the ingredient
Hydrolysed Chicken Cartilage Extract (approved ABN)
Definition of the ingredient
Hydrolysed chicken cartilage extract is derived from chicken (Gallus gallus) sternum cartilage. The fresh sternum cartilage is cut from the chicken carcass and then subjected to enzymatic hydrolysis using food grade proteases. The hydrolysate is then sterilised, filtered and spray dried.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Free flowing powder |
| Colour | Visual | Off-white to beige |
| Odour | Organoleptic | Characteristic |
| Characteristics | ||
| Solubility | Visual | Soluble (1.0% w/w in Water) |
| Ash | AOAC 942.05/Ph. Eur.2.4.16 | Not more than 12% |
| Fat | AOAC 922.06/F100 | Not more than 2% |
| Loss on drying | AOAC 930.15/Ph. Eur.2.2.32 | Not more than 5% |
| Bulk Density (Untapped) | USP<616>/Ph. Eur.2.2.42 | 0.40 to 0.60 g/cc |
| Particle Size | USP<786>/Ph. Eur.2.9.12 | 100% pass through 80 US mesh |
| Identification | ||
| Hydrolysed chicken cartilage extract | EP 9.0 Infrared Absorption Spectrophotometry (2.2.24) | IR/NIR fingerprint matches reference spectrum of hydrolysed chicken cartilage extract reference standard |
| Assay | ||
| Chondroitin Sulfate | USP CPC Titration | Not less than 20% w/w (On Dry Basis) |
| Hyaluronic Acid | EP 01/2017: 1472 | Not less than 10% w/w (On Dry Basis) |
| Hydrolysed Collagen Type II Calculated as Total Protein |
AOAC 992.15, Ph. Eur. 2.5.9 |
Not less than 60% w/w (On Dry Basis) |
| Average Molecular Weight (Mn) | Ph. Eur. 2.2.30 (GPC) | 1500 - 2500 Daltons |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Lead | USP<730>, AOAC 2013.06 | Not more than 0.2 ppm |
| Cadmium | USP<730>, AOAC 2013.06 | Not more than 0.1 ppm |
| Mercury | USP<730>, AOAC 2013.06 | Not more than 0.1 ppm |
| Arsenic | USP<730>, AOAC 2013.06 | Not more than 1.0 ppm |
| Microbiology | ||
| Total Microbial Count (TMC) | AOAC Petrifilm 990.12, Ph. Eur. 5.1.4 | Not more than 10,000 cfu/g |
| Total Yeast & Mold Count (TYMC) | AOAC Petrifilm 2014.05, Ph. Eur. 5.1.4 | Not more than 100 cfu/g |
| Escherichia Coli | USP<2022>, Ph. Eur. 5.1.4 | Negative/10g |
| Salmonella | USP<2022>, Ph. Eur. 5.1.4 | Negative/25g |
| Staphylococcus Aureus | USP<2022>, Ph. Eur. 5.1.4 | Negative/10g |
| 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. 100 '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 11 of the Order. | ||
Key to abbreviations
AOAC = Association of Official Analytical Chemists
BP = British Pharmacopoeia
EP = European Pharmacopoeia
HPLC = High-pressure liquid chromatography
ICP-MS = Inductively coupled plasma mass spectrometry
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia
CFU = Colony Forming Units
GPC = Gel Permeation Chromatography
CPC = United States Pharmacopoeia Cethylpyridinium Chloride (CPC) Titration