5 batch GLP
For pesticide registration in the agrochemical industry a Preliminary (5 Batch) Analysis is a pre-requisite according to 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
This involves the analysis of five or more production batches of the pesticide. The amount of active ingredient is assayed and any impurities above a set threshold must be identified and quantified. This work is usually performed to GLP (Good Laboratory Practice) standards.
Hall Analytical is unique in that we can perform all the testing required for 5 batch analysis in compliance with GLP standards, as well as being able to provide Dioxins analysis to GLP standards which is an additional requisite for some pesticide materials (24 D, Dicamba, MCPP, Prochloraz and others).
This saves our clients time and money as all testing is consolidated with a single supplier who can provide the complete analysis required for regulatory submission.
We undertake 5 batch analysis as a sequential process;
- General semi-quantitative screen by GC or HPLC with FID or UV detection to determine 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 with full client consultation, in an agreed format, for regulatory submission
Client confidentiality is assured and all results are fully discussed and explained.
Compounds which have dealt with include;