Standard for tridemorph active constituent

Version 1 August 2004

1. Description: the material shall consist of tridemorph together with related manufacturing impurities and shall be in the form of a yellow, oily liquid, free from visible extraneous matter and added modifying agents.

2. Common Name: tridemorph

3. Chemical Name (IUPAC): 2,6-dimethyl-4-tridecylmorpholine

4. CAS Number: 81412-43-3

5. Identity test: identity of the active constituent must be established by one or more of hte following methods: spectroscopic tests (IR spectrum, NMR, mass spectra), Chromatography (HPLC or GC retention time with reference compound) or any other suitable test method.

6. Composition: Tridemorph active constituent is a reaction mixture of C11-C14
4-alkyl-2,6-dimethylmorpholine homologues containing 60-70% of the 4-tridecyl isomer
6.1 Active constituent: 950 g/kg minimum

7. Analytical methods

• The analytical method used for the determination of the active constituent and toxicological significant impurities must be validated in accordance with the APVMA guidelines for the validation of analytical methods.
• Collaboratively tested standard CIPAC and AOAC methods for the analysis for the active constituent and any method submitted as a part of the new active constituent application that has been accepted by the APVMA are regarded as validated and do not require revalidation.
• Unless the scope of the collaborative method (CIPAC and AOAC) also includes toxicological significant impurities in the active constituent, validation data for impurities are required.

AOAC: Association of Official Analytical Chemists (The Official Methods of Analysis)
CIPAC: Collaborative International Pesticides Analytical Council