Standard—glyphosate-isopropylammonium manufacturing concentrate active constituent

Version: 
2
Effective Date: 
3 June 2015
1. Description: 

the material shall consist of an aqueous solution glyphosate-isopropylammonium together with related manufacturing impurities. It shall be white to light yellow viscous solution, free from visible extraneous matter and added modifying agents.

2. Common Name: 
Glyphosate-isopropylammonium
3. Chemical Name (IUPAC): 

monoisopropylammonium N-phosphonomethylglycinate

4. CAS Number: 
38641-94-0
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), Chromatographic tests (HPLC or GC retention time with reference compound) or any other suitable test method.
6. Composition: 

 

6.1 Active Constituent: must be prepared from glyphosate acid with 950 g/kg minimum purity. Glyphosate acid content of the manufacturing concentrate shall be declared. Glyphosate-isopropylammonium manufacturing concentrate usually contains 620 g/kg of glyphosate-isopropylammonium salt.

6.2 Toxicological Significant Impurities

  • Formaldehyde: 1.3 g/kg maximum
  • N-nitroso-N-phosphonomethylglycine: 1mg/kg maximum
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 ie, 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 potential for the product matrix to have an effect on the determination of the active constituent. 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).
  • Unless the scope of the collaborative method (CIPAC and AOAC) also includes toxicologically significant impurities in the active constituent, validation data for impurities are required.

 

 

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