Program

Tea Tree Oil

Research Organisation

Southern Cross University

Objective Summary

The objective of this study is to determine the changes in tea tree oil composition and peroxide value over 12 months under simulated in-use conditions. The proposed study protocol is based on principles outlined by the EMEA (European Agency for the Evaluation of Medicinal Products) in ‘Guidance On In-Use Stability of Human Medicinal Products’. It is proposed to analyse the chromatographic compositional profile in predetermined time intervals using the GC method outlined in the Tea Tree Oil monograph 04/2002:1837 of the European Pharmacopoeia 4.1 and to concurrently determine the peroxide value using the peroxide value test method as per British Pharmacopoeia 2003 (Ph. Eur. Method 2.5.5). Both proposed analysis methods are based on authoritative European reference texts and should be acceptable to the SCCP and related relevant European authorities.