Black boned chicken powder
Compositional guideline for 'Black boned chicken powder' permitted for use in listed medicines
Name of the ingredient
Dried powder derived from Gallus gallus domesticus Brisson (ABN), commonly known as black boned chicken
Definition of the ingredient
The feathers, head, legs, claws and visceral organs are removed and the remaining part, which includes meat, skin and bones, is cooked in yellow rice wine, dried at 70°C, and then ground to fine powder.
Specific condition
The black boned chickens used in manufacturing must have veterinary certificate indicating the black boned chickens are obtained from healthy flocks and are suitable for human consumption.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | Brown black colour |
| Odour | Organoleptic | Fresh chicken smell |
| Loss on drying | Determination of loss by drying (PPRC 1992 Appendix 9.2) | ≤ 5% |
| Not specified - appropriately validated identification test should be used | ||
| Protein | Not specified - appropriately validated method should be used | ≥ 50% |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Pesticide residues and environmental contaminants | ||
| Microbiology | ||
| Microbiology | ||
| Notes | ||
| Total heavy metals | USP | ≤ 10 ppp* |
| Arsenic | USP | ≤ 5 ppm* |
| Antibiotic residue | Food Standards Code in relation to chicken and poultry meat | Complies with the maximum residue limits |
| Total aerobic microbial count | BP | ≤ 104 per g |
| Yeast and mould | AGRD2 | ≤ 102 per g |
| Enterobacteria | AGRD2 | ≤ 102 per g |
| E. coli | AGRDs | None in 1 g |
| Salmonella | AGRD2 | None in 10 g |
| S. aureus (as coagulase postive Staphylococci) | ≤ 100 per g | |
| While specifications for this substance include limits for objectionable microorganisms, it is the product into which the substance is formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' - external site mandates that any finished product which contains the ingredient, alone or in combination, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
| * These specifications are expressed with respect to the mass of the substance before cooking or after reconstitution to a moisture content equivalent to that of the fresh black boned chicken material. | ||
Key to abbreviations
AGRD2 = Australian Guidelines for the Registration of Drugs, Volume 2
BP = British Pharmacopoeia
PPRC = Pharmacopoeia of the People Republic of China
USP = United States Pharmacopoeia