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Compositional guideline: Black boned chicken powder

19 April 2011

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.

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Brown black colour
Odour Organoleptic Fresh chicken smell
Characteristics
Loss on drying Determination of loss by drying (PPRC 1992 Appendix 9.2) ≤ 5%
Identification
Not specified - appropriately validated identification test should be used
Assay
Protein Not specified - appropriately validated method should be used ≥ 50%
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Incidental metals and non-metals
Total heavy metals USP ≤ 10 ppp*
Arsenic USP ≤ 5 ppm*
Pesticide residues and environmental contaminants
Antibiotic residue Food Standards Code in relation to chicken and poultry meat Complies with the maximum residue limits
Microbiology
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
Microbiology
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' 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.
Notes
* 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