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Name of the ingredient
Conifer phytosterol complex (AAN)
Definition of the ingredient
Conifer phytosterol complex is a by-product of the wood pulping process used for coniferous trees. There are four main steps in the production of conifer phytosterol complex: (i) alkaline digestion of wood chips to produce tall oil soap; (ii) a solvent extraction process to yield an organic phase; (iii) complexation-washing process of the organic extract to produce the crude sterol mixture; and, (iv) crystallisation of purified sterols from the crude sterol mixture. The bulk anhydrous substance meets the requirements shown in the following table.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | White to off-white crystalline, waxy powder, free from foreign matter |
| Odour | Organoleptic | None or slight chemical odour |
| Characteristics | ||
| Residue on ignition | USP <281> | ≤ 0.1% |
| Loss on drying | Weight loss after 2 h at 96°C under vacuum | ≤ 5% |
| Identification | ||
| GC | Chemical profile of major components comply with authenticated reference material | |
| Assay | ||
| Phytosterol content | GC | ≥ 95% |
| Sitosterol | GC | 36 - 79%* |
| Sitostanol (Stigmastanol) | GC | 6 - 34%* |
| Campesterol | GC | 4 - 25%* |
| Campestanol (Ergostanol) | GC | 2 - 12%* |
| Related substances (C15-C25 aliphatic alcohols) | GC | ≤ 0.5%* |
| Notes | ||
|
* % w/w on an 'anhydrous' basis |
||
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Solvent residues | ||
| Solvents | USP <467> | < 0.5% |
| Incidental metals and non-metals | ||
| Total heavy metals | US EPA method 200.15 (ICP/AES) | ≤ 10 ppm |
| Lead | US EPA method 7000A (Graphite furnace AAS) | ≤ 0.25 ppm |
| Arsenic | US EPA method 200.15 (ICP/AES) | ≤ 5 ppm |
| Cadmium | US EPA method 200.15 (ICP/AES) | ≤ 1 ppm |
| Mercury | US EPA method 245.1 (CVAA) | ≤ 1 ppm |
| Pesticide residues and environmental contaminants | ||
| Pesticide residues | Ph Eur 2.8.13 | Complies |
| Microbiology | ||
| Total aerobic count | Sponsor's method | ≤ 104 CFU/g |
| Combined moulds & yeasts | Sponsor's method | ≤ 100 CFU/g |
| Coliforms | Sponsor's method | Negative |
| E. coli | Sponsor's method | Negative |
| Salmonella | Sponsor's method | Negative |
| 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' - 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. | ||
Key to abbreviations
BP = British Pharmacopoeia
CFU = Colony forming units
CVAA = Cold vapour atomic absorption spectrometry
GC = Gas Chromatography
ICP/AES = Inductively coupled plasma-Atomic emission spectrometry
Ph Eur = European Pharmacopoeia
US EPA = United States Environmental Protection Agency
USP = United States Pharmacopoeia