Proposed standards for the active constituents amicarbazone and florasulam

The APVMA is proposing to set active constituent standards for amicarbazone and florasulam under s. 42 (3) (e) of the Agricultural and Veterinary Medicines Chemicals Code Regulations 1995, and invites comment from 26 March 2013 to 23 April 2013 on the proposed active constituent standards for active constituents amicarbazone and florasulam.

The APVMA will only consider comments relating:

• chemistry and manufacture
• toxicity

See a copy of the draft standard for amicarbazone active constituent

See a copy of the draft standard for florasulam active constituent

For more information, see page 12 of the APVMA Gazette No. 6 – 26 March 2013.

Please send your comments by email to pest pestchemistry@apvma.gov.au or by mail to:

Manager, Pesticides Chemistry Evaluation Section
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Enquiries:

Telephone: +61 2 6210 4936
Fax: +61 2 6210 4840
Email: pestchemistry@apvma.gov.au

Draft standard for amicarbazone active constituent

Version 1

1. Description: the material shall consist of amicarbazone together with related manufacturing impurities and shall be in the form of off-white odourless crystals, free from visible extraneous matter and added modifying agents.

2. Common Name: amicarbazone

3. Chemical Name (IUPAC): 4-amino-N-tert-butyl-4,5-dihydro-3-isopropyl-5-oxo-1,2,4-1H -triazole-1-carboxamide

4. CAS Number: 129909-90-6

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

6. Composition
6.1 Active constituent: 940 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.
• Validation data for related impurities are not be required.

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

Draft standard for florasulam active constituent

Version 1

1. Description: the material shall consist of florasulam together with related manufacturing impurities and shall be in the form of an off-white odourless powder, free from visible extraneous matter and added modifying agents.

2. Common Name: florasulam

3. Chemical Name (IUPAC): 2',6',8-trifluoro-5-methoxy[1,2,4]triazolo[1,5-c]pyrimidine-2-sulfonanilide

4. CAS Number: 145701-23-1

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

6. Composition
6.1 Active constituent: 970 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.
• Validation data for related impurities are not be required.

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

* For florasulam manufacturing concentrate, the purity of technical florasulam in manufacturing the concentrate is 970 g/kg minimum on a dry weight basis (excluding water and all other added constituents).