5 batch GLP
A preliminary 5 batch analysis is a prerequisite for pesticide registration in the agrochemical industry. This is enforced by various regulatory directives:
- Europe: Regulation (EC) 1107/2009, Commission Regulation (EU)
- 283/2013, SANCO 3030/99
- US-EPA: OPPTS 830.1550, OPPTS 830.1700, OPPTS 830.1800
- Brasil: e.g. SINDAG, Circular Letter no 075/2007; CTA, Circular Letter Sept/2011
- Argentina: SENASA requirements
- Worldwide: FAO or IUPAC specifications on toxicological relevant impurities
Five or more production batches of the pesticide are analysed. The amount of active ingredient is assayed and any impurities above a set threshold must be identified and quantified, usually under good laboratory practice (GLP) standards.
Hall Analytical performs all the testing required for 5 batch analysis in compliance with GLP standards, making us unique. Our scientists also provide dioxins analysis to GLP standards—an additional requirement for some pesticide materials (24 D, Dicamba, MCPP, Prochloraz, and others). Having all testing required for a regulatory submission consolidated with a single supplier saves you time and money.
Our sequential 5 batch analysis process:
- Perform a general semi-quantitative screen by GC or HPLC with FID or UV detection. This determines all components present above the 0.1% w/w threshold
- Identify and characterise the impurities by GC-MS and/or LC-MS
- Obtain the impurities via an approved third party specialist chemical synthesis company
- Develop assay procedures for the impurities and active substances according to SANCO guidelines
- Provide a full GLP report in partnership with our client. We’ll work with you to ensure that your submission is accepted, providing it in the format of your choice.
Client confidentiality is assured and all results are fully discussed and explained.