Compositional guideline: Conifer phytosterol complex
Definition
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.
| Characteristic | Standard | Method |
|---|---|---|
| Appearance | Crystalline, waxy powder. No foreign matter | |
| Colour | White to off-white | |
| Odour | None or slight chemical odour | |
| Identification | Chemical profile of major components matches standard. | GC method |
| Phytosterol content | NLT 95% | GC method |
| Sitosterol | 36% - 79%* | GC method |
| Sitostanol (Stigmastanol) | 6% - 34%* | GC method |
| Campesterol | 4% - 25%* | GC method |
| Campestanol (Ergostanol) | 2% - 12%* | GC method |
| Related substances (C15 - C25 aliphatic alcohols) | NMT 0.5%* | GC method |
| Loss on drying (water) | NMT 5% | Weight loss after 2 hr at 96°C under vacuum |
| Solvents | NMT 0.5%. | USP<467> |
| Residue on ignition | NMT 0.1% | USP<281> |
| Total Heavy Metals | NMT 10 mg/kg | EPA# method 200.15 (ICP scan) |
| Cadmium | NMT 1 mg/kg | EPA method 200.15 (ICP scan) |
| Mercury | NMT 1 mg/kg | EPA method 245.1 (CVUV scan) |
| Arsenic | NMT 5 mg/kg | EPA method 200.15 (ICP scan) |
| Lead | NMT 0.25 mg/kg | EPA Method 7000A (Graphite Furnace AAS) |
| Pesticide residues | Complies with limits specified in Ph. Eur. 2.8.13 | Ph. Eur. |
| Total aerobic count | NMT 10,000 CFU/g | Sponsor's method |
| Combined moulds & yeasts | NMT 100 CFU/g | Sponsor's method |
| Coliforms | Negative | Sponsor's method |
| E. coli | Negative | Sponsor's method |
| Salmonella | Negative | Sponsor's method |
| * % w/w on an 'anhydrous' basis. # US Environmental Protection Agency, Office of Research and Development, Environmental Monitoring and Support Laboratory, Cincinnati, Ohio. NMT = not more than NLT = not less than |
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