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Leptospermum scoparium oil

Compositional guideline for 'Leptospermum scoparium oil' permitted for use in listed medicines

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Name of the ingredient

Leptospermum scoparium oil (AHS)

Definition of the ingredient

This compositional guideline is specific to the oil derived by steam distillation from the crushed leaves and terminal branches of the Manuka tree Leptospermum scoparium. There are no other extraction processes or ingredients added to the oil.

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Clear yellow liquid
Characteristics
Relative density BP (Appendix V G) 0.95 – 0.98 g/mL at 20°C
Refractive index BP (Appendix V E) 1.4960 – 1.5060
Identification
Chemical 'fingerprint' GC[1] Complies with authenticated reference material
Assay
α-Cubebene GC[1] 2.0 - 7.0% w/w
α-Copaene GC[1] 2.5 - 7.5% w/w
β-Selinene GC[1] 1.0 - 6.0% w/w
α-Selinene GC[1] 2.0 - 7.0% w/w
Calamanene GC[1] 9.0 - 18.0% w/w
δ-Cadinene GC[1] 3.0 - 8.0% w/w
Cadina-1,4-diene GC[1] 3.0 - 8.0% w/w
Flavesone GC[1] 3.0 - 8.0% w/w
iso-Leptospermone GC[1] 2.0 - 7.0% w/w
Leptospermone GC[1] 10.0 - 20.0% w/w
Total triketone content* GC[1] ≥25% w/w
Notes

*Total of flavesone, leptospermone and iso-leptospermone
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Residual solvents
Residual solvents are not tested for** See notes below** See notes below**
Pesticide residues and environmental contaminants
Current BP test and limits BP (Appendix XI L, Pesticide residues) Complies
Incidental metals and non-metals

While ingredient manufacturers are encouraged to include limits for Incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, must comply with the acceptance criteria set in the United States Pharmacopeia - National Formulary (USP-NF) general chapter '<2232> Elemental Contaminants in Dietary Supplements'. When testing is performed at the raw material stage, calculation of the total daily exposure in the finished product should be performed. This calculation is based on the quantity of each ingredient present in the product, the maximum potential contamination given the proposed limits for each raw material and the daily dose of the product.
Microbiology

While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are 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 that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order.
Notes

** As the oil is derived by steam distillation from the crushed leaves and terminal branches of the Manuka tree Leptospermum scoparium, and there are no other extraction processes or ingredients added to the oil, there should be no residual solvents.

Footnotes

[1] As described in: Douglas, M. H., van Klink, J. W., Smallfield, B. M., Perry, N. B., Anderson, R. E., Johnstone, P., & Weavers, R. T. (2004). Essential oils from New Zealand manuka: triketone and other chemotypes of Leptospermum scoparium. Phytochemistry, 65(9), 1255-1264.

Abbreviations

AHS = Australian Herbal Substance

BP = British Pharmacopoeia

GC = Gas Chromatography

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