Compositional guideline: Sugar cane wax alcohols (SCWA)
| Parameter | Limits | Methods |
|---|---|---|
| Colour and Odour | Off-white and odourless | |
| Structure | Microcrystalline powder | |
| Solubility | Insoluble in water, hexane, methanol and ethanol; slightly soluble in chloroform | |
| Identification | Of the individual higher aliphatic alcohols | GC |
| Melting Point | 78.0 - 82.0°C | |
| Loss on drying | <1.0% | |
| Ignition Residue | <0.85% | |
| Heavy Metals | <0.001% (10 ppm) | USP23 |
| Sodium content | <0.01% (100 ppm) | AA or flame photometry |
| Potassium content | <0.45% (4500 ppm) | AA or flame photometry |
| Total content of higher aliphatic primary alcohols | ≥85.0%, but <90.0% by weight | GC |
| 1-tetracosanol (C24H49OH) | 0.0-0.3% | GC |
| 1-hexacosanol (C26H53OH) | 3.0-8.0% | GC |
| 1-heptacosanol (C27H55OH) | 0.1-3.0% | GC |
| 1-octacosanol (C28H57OH) | 60.0-70.0% | GC |
| 1-nonacosanol (C29H59OH) | 0.1-2.0% | GC |
| 1-triacontanol (C30H61OH) | 10.0-15.0% | GC |
| 1-dotriacontanol (C32H65OH) | 5.0-10.0% | GC |
| 1-tetratriacontanol (C34H69OH) | 0.1-5.0% | GC |
| General# | Requirement | |
| Microbiological Controls | Complies with specific limits as dictated in the AGRD** Vol.2 | |
| Solvent Residues | Complies with limits for specific solvents in the ICH topic Q3C*** | |
| Pesticide Residues | Complies with the limits set out in the Ph. Eur. 1997, (2.8.13) | |
| # Refers to finished products incorporating this substance ** Australian Guidelines for the Registration of Drugs, Volume 2. *** International Conference of Harmonisation Topic Q3C Impurities: Guidelines for Residual Solvents (1997) |
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