Name of the ingredient
Sugar cane wax alcohols (SCWA) (AAN)
Definition of the ingredient
SCWA is the powdered crystalline extract obtained from the wax of the stem and leaves of the sugar cane plant (Saccharum officinarum L.) by a saponification/extraction process. The material consists primarily of high molecular weight straight-chain alcohols and aliphatic acids.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Off-white |
| Odour | Organoleptic | Odourless |
| Characteristics | ||
| Residue on ignition | USP | < 0.85% |
| Loss on drying | BP | < 1.0% |
| Melting Point | 78.0 - 82.0°C | |
| Identification | ||
| GC profile | GC | GC chromatogram shows peaks for the individual higher aliphatic primary alcohols specified in the assay |
| Assay | ||
| Total content of higher aliphatic primary alcohols | GC | ≥ 85.0% by weight |
| 1-tetracosanol (C24H49OH) | GC | 0.0 - 0.3% |
| 1-hexacosanol (C26H53OH) | GC | 3.0 - 8.0% |
| 1-heptacosanol (C27H55OH) | GC | 0.1 - 3.0% |
| 1-octacosanol (C28H57OH) | GC | 60.0 - 70.0% |
| 1-nonacosanol (C29H59OH) | GC | 0.1 - 2.0% |
| 1-triacontanol (C30H61OH) | GC | 10.0 - 15.0% |
| 1-dotriacontanol (C32H65OH) | GC | 5.0 - 10.0% |
| 1-tetratriacontanol (C34H69OH) | GC | 0.1 - 5.0% |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Solvent residues | ICH topic Q3C* | Complies |
| Incidental metals and non-metals | ||
| Total heavy metals | USP 23 | < 10 ppm |
| Sodium content | AAS or flame photometry | < 0.01% (100 ppm) |
| Potassium content | AAS or flame photometry | < 0.45% (4500 ppm) |
| Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) | BP (Vol IV, Appendix XI L, Pesticide residues; Ph Eur method 2.8.13) | Complies |
| Microbiology | While substance manufacturers are encouraged to 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. | |
|
Notes * International Conference on Harmonisation Topic Q3C- Impurities: Guidelines for residual solvents (1997) |
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Key to abbreviations
AAS = Atomic absorption spectrometry
BP = British Pharmacopoeia
GC = Gas chromatography
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia
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