Compositional guideline: Bovine colostrum powder
Definition
Bovine Colostrum Powder (BCP) is derived from the milking of cows (Bos taurus) after calving. BCP is a lactose- and fat-reduced, high-protein product, which is manufactured without addition of additives or artificial ingredients. BCP contains a number of bioactive components, which are not present or are present in very low amounts in normal cow's milk. These include a number of growth factors (e.g. insulin-like growth factors I and II) and antimicrobial factors (e.g. immunoglobulins), cytokines, enzymes, hormones, and other components.
Specific condition(s)
The colostrum must be obtained either from Australian herds or herds from countries which are considered BSE-free, which are registered for milk production for human consumption. Animal origin information would need to be provided with all new applications to list medicines containing BCP. In some instances further information may be required for evaluation by TGAL in relation to products containing these substances (see Supplementary Requirements for Therapeutic Goods for Minimising the Risk of Transmitting Transmissible Spongiform Encephalopathy (TSE) <http://www.tga.gov.au/docs/html/tsesupp.htm>).
| Test | Specification | Method |
|---|---|---|
| Appearance | Free-flowing, pale yellow powder. | |
| Properties | Soluble in water. Mild odour of milk when contacted with moisture. | |
| Moisture | NMT 7% m/m | AS 2300.1.1 (1988) |
| Ash (@550°C) | NMT 8% m/m | AS 2300.1.5 (1988) |
| Total nitrogen (TN)* | For information | AS 2300.1.2 (1991) |
| Non-protein nitrogen (NPN)* | For information | AS 2300.1.2.2 (1988) |
| True protein | NLT 60% m/m | (TN-NPN)% x 6.38 |
| Protein | NLT 60% m/m | AS 2300.1.2 (1991) |
| Lactose (monohydrate) | NMT 15% m/m | UV assay following enzymatic hydrolysis and oxidation (Boehringer Mannheim) |
| IgG | NLT 10% m/m | Chromatographic** |
| Microbial limits | Complies with TGA guidelines stipulated in the Australian Guidelines for the Registration of Drugs Vol. 2 | |
| Residues: Heavy metals Agricultural and Veterinary chemicals |
Subject to Food Standards Australia and New Zealand Code for dairy products. Where there is no applicable Food Standard, the BP test for heavy metals applies (2 ppm calculated as lead) and also the BP requirements for pesticide residues. | |
| NMT = not more than NLT = not less than * Used to calculate the value for true protein. ** The chromatographic method should be validated for the specific quantitation of the IgG component. A typical procedure could be to use affinity chromatography involving a protein A-sepharose column. |
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