Deer velvet antler slice
Compositional guideline for 'Deer velvet antler slice' permitted for use in listed medicines
Name of the ingredient
Deer velvet antler slice (ABN)
Definition of the ingredient
The above-named substance is sliced, dried deer antler, including velvet, which has been obtained from the stags of the following deer species: red deer (Cervus elaphus), elk/wapiti (Cervus canadensis) or a crossbreed of the two. The age of antler at the time of removal is between 40–85 days from previous harvest or casting.
The stags from which the substance is obtained must have been bred and raised in New Zealand and fulfil the requirements for animals suitable for human consumption (as provided by the Animal Products Act 1999 (New Zealand) and the regulations made under that Act). Antlers must be removed according to the National Velvetting Standards Body (NVSB) Code of Practice1.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | Brown solid disks |
| Loss on drying | BP (Appendix IX D) | No more than 15% w/w |
| TLC | NZFSA OMAR 06/22: Korea: export of sliced deer velvet | Matches standard |
| Calcium | ICP or AAS | 0.1-17.7% w/w |
| Total protein as amino acids | AOAC 982.30, AOAC 988.15, AOAC 985.28 | 39.4-98.5% (sum of all procedures) |
Notes
- National Velvetting Standards Body (NVSB) (April 2009). Farmer Velvet Antler Removal Manual. Deer Industry New Zealand.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Incidental metals and non-metals | ||
| Pesticide residues and environmental contaminants (including agricultural and veterinary substances): | ||
| Other organic or inorganic impurities or toxins | ||
| Microbiology | ||
| Ethanol | BP (Appendix VIII L, Residual solvents), Ph Eur method 2.4.24) | No more than 0.5% w/w |
| Lead | ICP or AAS | No more than 1.0 ppm |
| Arsenic | ICP or AAS | No more than 3.0 ppm |
| Cadmium | ICP or AAS | No more than 0.05 ppm |
| Mercury | ICP or AAS | No more than 0.1 ppm |
| Lignocaine | GC-MS or HPLC-MS | No more than 0.1 ppm |
| Xylazine | GC-MS or HPLC-MS | No more than 0.5 ppm |
| Ash | Gravimetric | 1.5-47.6% |
| 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 which 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
AAS = Atomic absorption spectrometry
AOAC = Association of Official Analytical Communities
BP = British Pharmacopoeia
GC = Gas chromatography
HPLC = High-pressure liquid chromatography
ICP = Inductively coupled plasma spectrometry
MS = Mass spectrometry
NZFSA OMAR = New Zealand Food Safety Authority Overseas Market Access Requirements
Ph Eur = European Pharmacopoeia
TLC = Thin layer chromatography