请教各位老师环丙氨嗪(2-环丙氨基-4,6-二氨基-S-三嗪)的理化性质
Cyromazine
白色结晶性粉末
熔点:219-222℃
Description: the material shall consist of cyromazine together with related manufacturing impurities and shall be in the form of colourless crystals, free from visible extraneous matter and added modifying agents.
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.
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.
Cyromazine
白色结晶性粉末
熔点:219-222℃
Description: the material shall consist of cyromazine together with related manufacturing impurities and shall be in the form of colourless crystals, free from visible extraneous matter and added modifying agents.
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.
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.