1. Description: the material shall consist of
pencycuron together with related manufacturing impurities and shall be in the
form of colourless crystal, free from visible extraneous matter and added
modifying agents.
2. Common Name: pencycuron
3. Chemical Name (IUPAC): 1-(4-chlorobenzyl)-1-cyclopentyl-3-phenylurea
4. CAS Number: 66063-05-6
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. Composition
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.
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.
2. Common Name: pencycuron
3. Chemical Name (IUPAC): 1-(4-chlorobenzyl)-1-cyclopentyl-3-phenylurea
4. CAS Number: 66063-05-6
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. Composition
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.
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.
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