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Compositional guideline: Sugar cane wax alcohols (SCWA)

31 May 2017

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.

Table 1. Ingredient specific requirements
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%
Table 2. Incidental constituents
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)

Key to abbreviations

AAS = Atomic absorption spectrometry

BP = British Pharmacopoeia

GC = Gas chromatography

Ph Eur = European Pharmacopoeia

USP = United States Pharmacopoeia