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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' 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