Name of the ingredient
alpha (α)-casozepine enriched hydrolysed milk protein (AAN)
Definition of the ingredient
The above named substance is a low-lactose, spray dried powder form of a protein hydrolysate of bovine (Bos taurus) skim milk. Alpha-casozepine is a decapeptide from αS1-casein.
Specific conditions
The milk used in the manufacture of the substance must be sourced either from Australian herds or herds from countries which are considered BSE-free, and which are registered for milk production for human consumption. The milk shall comply with the maximum residue limits for agricultural and veterinary chemicals established for milk in Standard 1.4.2 of the Australia New Zealand Food Standards Code.
Animal origin information would need to be provided with all new applications to list medicines containing α-casozepine enriched hydrolysed milk protein. In some instances further information may be required for evaluation by the TGA in relation to products containing this substance (see Supplementary information on Transmissible Spongiform Encephalopathies (TSEs) regulation).
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | White/cream free flowing powder |
| Characteristics | ||
| Loss on drying | IDF 26A (102°C for 2 h) | Not more than 5.5% |
| pH of solution | IDF 115 A (pH meter) | 5.0-7.5 |
| Ash | IDF 27 (550°C, furnace) | Not more than 20% (as is) |
| Identification | ||
| Chromatographic profile | HPLC1 | Profile consistent with that of authenticated reference material |
| Assay | ||
| Content of alpha (α)-casozepine | HPLC1 | Not less than 1.8% |
| Protein (as N x 6.38) | IDF 20 B (Kjeldahl method) | Not less than 73% (as is) |
| Lactose | Enzymatic | Not more than 1.0% |
| Notes | ||
|
||
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Lead | AAS | Not more than 1 ppm |
| Arsenic | AAS | Not more than 3 ppm |
| Cadmium | AAS | Not more than 0.05 ppm |
| Mercury | AAS | Not more than 0.1 ppm |
| Sodium | Flame spectrometric | Not more than 6% |
| Potassium | Flame spectrometric | Not more than 0.2% |
| Calcium | AAS | Not more than 0.5% |
| Magnesium | AAS | Not more than 0.1% |
| Phophorous | Spectrometric | Not more than 1% |
| Other organic or inorganic impurities and toxins | ||
| Aflatoxins | ISO 14501 | Complies |
| Lysinoalanine2 | HPLC | Not detected |
| Nitrite/nitrosamines2 | Chromatography | Not detected |
| Microbiology | ||
| 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 that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
| Notes | ||
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Key to abbreviations:
AAS = atomic absorption spectroscopy
BP = British Pharmacopoeia
HPLC = high-pressure liquid chromatography
IDF = International Dairy Federation
ISO = International Standards Organization
Ph Eur = European Pharmacopoeia