We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
Name of the ingredient
Chicken sternum cartilage powder (Approved Biological Name (ABN), ingredient ID: 143048).
Definition of the ingredient
Chicken sternum cartilage powder is a non-GMO substance derived from sanitised chicken sternum cartilage which are grounded and subjected to a two-step dehydration process using potassium chloride. The dehydration process is undertaken at a temperature sufficient to eliminate pathogens of concern. After drying the ground sternums are milled and sieved. Chicken sternum cartilage powder is derived from the sternum of chickens that are fit for human consumption.
CAS Number of Active Constituent:
Collagen: 9007-34-5
Table 1. Ingredient specific requirements
|
Test |
Method reference |
Acceptance criteria |
|---|---|---|
|
Description |
||
|
Description |
Organoleptic |
White/cream, odourless powder |
|
Characteristics |
||
|
Loss on Drying |
USP<731> |
No more than 10% |
|
Bulk Density |
USP<616> |
0.45 to 0.75 g/cm3 |
|
Tap Density |
USP<616> |
0.75 to 1.05 g/cm3 |
|
Particle Size Wt. 100 mesh |
USP<786> |
No less than 60% (w/w) |
|
Identification |
||
|
Identification |
FT-IR; USP<197NIR> |
IR fingerprint matches reference spectrum of chicken sternum cartilage powder reference standard |
|
Assay |
||
|
Total Collagen |
HPLC-UV/Fluorescence1 |
No less than 25.0% |
|
Undenatured Type II Collagen |
ELISA2 |
No less than 3.0% |
Table 2. Incidental constituents
|
Test |
Method reference |
Acceptance criteria |
|---|---|---|
|
Incidental metals and non-metals |
||
|
Potassium |
USP<730> |
14.2 to 19.4% |
|
Chloride |
AOAC 963.05, 971.27 AOAC 986.26 |
10% to 25% |
|
Arsenic |
USP<730> |
No more than 1.5 ppm |
|
Cadmium |
USP<730> |
No more than 0.5 ppm |
|
Lead |
USP<730> |
No more than 0.5 ppm |
|
Mercury |
USP<730> |
No more than 0.5 ppm |
|
Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) |
||
|
Pesticides |
USP <561> |
Complies |
|
Antibiotics |
LC MS/MS |
Complies with Australia New Zealand Food Standards Code, Standard 1.4.2 (Schedule 20) – Maximum residue limits for chicken meat) |
|
Microbiology |
||
|---|---|---|
|
Microbial testing aligned with Therapeutic Goods Order 100 or relevant updates |
||
|
Total Aerobic Microbial Count |
USP<2021> |
No more than 3000 CFU/g |
|
Enterobacterial Count |
USP<2021> |
No more than 10 MPN/g |
|
Total Molds & Yeast Count |
USP<2021> |
No more than 100 CFU/g |
|
Escherichia coli |
USP<2022> |
Absent in 10g |
|
Salmonella |
USP<2022> |
Absent in 10 g |
|
Staphylococcus aureus |
USP<2022> |
Absent in 10 g |
|
Bacillus cereus |
FDA BAM |
No more than 100 CFU/g |
|
Genus Listeria |
AOAC 997.03 |
Negative |
|
Pseudomonas aeruginosa |
USP<62> |
Absent |
|
Staphylococcus enterotoxin |
AOAC 2007.06 |
Negative |
|
Coliform |
AOAC 992.30 |
No more than 3 MPN/g |
|
Clostridium perfringens |
AOAC 976.30 |
No more than 10 CFU/g |
|
Sulfite Reducing Bacteria |
ISO 15213:2003(E) |
No more than 10 g |
|
Notes |
||
|
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. |
||
|
Notes |
||
|
1. HPLC-UV/Fluorescence: Column: Agilent Zorbax Eclipse Plus C18, 75 x 4.6 mm, 3.5 micron particle size; Guard Column Eclipse AAA 12.5 x 4.6 mm, 5 micron; Column Temperature: 40°C; Flow Rate: 2 mL/min; Injection Volume: 0.5 microliters; Diode array wavelength - 1: 338 nm ±10 nm; 390 nm ± 20 nm; Diode array wavelength - 2: 262 nm ±16 nm; 324 nm ± 8 nm; Fluorescence EX wavelength: 340 nm, Fluorescence EM wavelength: 450 nm; Mobile phase A: Water; Mobile phase B: Methanol; Mobile phase C: Acetonitrile; Mobile phase D: 10 mM Na2HPO4, 10 mM Na2B4O7, pH 8.2; Mobile phase gradient 0.0 min 100% D; 0.5 min 100% D; 10.8 min 5.6% A; 25.7% B; 25.7% C; 43% D 11.0 min 10% A; 45% B; 45% C; 13.0 min 10% A; 45% B; 45% C; 13.5 min 100% D. Hydroxyproline represents about 12.6% of collagen by mass. Use the following equation to convert hydroxyproline content into total collagen: Hydroxyproline level (mg/g sample) × 8 = Total Collagen (mg/g sample) 2. ELISA Test Methodology - % Undenatured type-II collagen: Incubator shaker temperature: 4°C; Incubator shaker speed: 110 rpm; Centrifuge speed: 600 g and 15200 g; Centrifuge temperature: 4°C; Plate reader: 490 nm; Data for collagen standards fit to a 4-parameter logistic equation: Y = d + (a-d) / (1+(X/c) b)
|
||
Key to abbreviations:
ABN = Approved Biological Name
AOAC = Association of official analytical collaboration
CFU = Colony-Forming Unit
ELISA = Enzyme-linked immune-sorbent assay
FDA BAM = Food and Drug Administration`s Bacteriological Analytical Manual
FT-IR = Fourier-transform infrared spectroscopy
GMO = Genetically modified organism
HPLC = High-pressure liquid chromatography
ISO = International organisation for standardisation
LC MS/MS = Liquid chromatography coupled with tandem mass spectrometry
MPN = Most Probable Number
Ph Eur = European pharmacopoeia
USP = United States pharmacopoeia
|
Version |
Description of change |
Effective date |
|
1.0 |
Original |
3/7/2023 |