This consultation closed on 26 February 2013
Consultation period29 January 2013 to 26 February 2013
The APVMA invites comment from 29 January 2013 to 26 February 2013 on proposed changes to the current standard for the active constituent thiacloprid. The purpose of the change is to update the standard in accordance with the FAO standard published in 2010.
1. (Description) from:
- The material shall consist of thiacloprid together with related manufacturing impurities and shall be a yellow powder, free from visible extraneous matter and added modifying agents.
- The material shall consist of thiacloprid together with related manufacturing impurities, in the form of a white to light brown coloured crystalline powder, free from visible extraneous matter and added modifying agents.
6.1 (Composition) from:
- Active constituent: 985 g/kg minimum
- Active constituent: 975 g/kg minimum
See a copy of the new proposed standard for thiacloprid
For more information, see page 17 of the APVMA Gazette No. 2 – 29 January 2013.
Please send your comments by email to firstname.lastname@example.org or by mail to:
Manager, Pesticides Chemistry Evaluation Section
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2609
Telephone: +61 2 6210 4936
Fax: +61 2 6210 4840
Draft standard for thiacloprid active constituent
1. Description: the material shall consist of thiacloprid together with related manufacturing impurities, in the form of a white to light brown coloured crystalline powder, free from visible extraneous matter and added modifying agents.
2. Common Name: thiacloprid
3. Chemical Name (IUPAC): (Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide
4. CAS Number: 111988-49-9
5. Identity test: identity of the active constituent must be established by one or more of the following methods:spectroscopic tests (IR spectrum, NMR, mass spectra), Chromatography (HPLC or GC retention time with reference compound) or any other suitable test method.
6.1 Active constituent: 975 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.
- The APVMA guidelines on validation of analytical methods state that "Analytical methods described in CIPAC handbooks and AOAC International Manual, and in recognized pharmacopoeias [BP, BP (Vet), Ph Eur and USP] for a particular active constituent or formulation are regarded as validated and do not require revalidation. However, the suitability of these methods must be verified under actual conditions of use i.e., the selectivity and accuracy of the method should be demonstrated for the published method when applied to the relevant sample matrix and laboratory conditions.
- When a CIPAC or AOAC method is used for the assay of an active constituent in a bulk active constituent, there is no matrix. The registrants need to check the specificity of the method to ensure there is no interference from impurities or degradation products. However, determination of accuracy of the method is not required as there is no matrix effect. However, when a CIPAC or AOAC method is used for the assay of an active constituent in a formulated product, determination of both specificity and accuracy is required as the matrix is relevant in formulated products (formulated products have different composition and quantities of excipients).
- Refer to Guidelines for the Validation of Analytical Methods for Active Constituent, Agricultural And Veterinary Chemical Products.
- 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