Your Trusted Partner for Technical Grade Material Characterization
When it comes to registering agrochemicals, regulatory authorities require detailed data on the composition of the technical grade material. One of the most critical components of this submission is the 5-batch analysis report, which plays a central role in gaining regulatory approvals worldwide.
Eurofins Advinus specialises in delivering high-quality, GLP-compliant 5-batch analysis reports that meet global regulatory expectations. Our in-depth analytical services are designed to provide complete clarity on your technical material—helping you move forward with confidence and speed.
What Does Our 5-Batch Analysis Include?
We follow a scientifically rigorous and phased approach to ensure that every constituent of your material is identified, quantified, and reported accurately.
- Pre-Screening for Total Composition
We start with a comprehensive screening of your material, assessing:
- Active ingredient content
- Impurity profile
- Toxicologically significant impurities
- Residual solvents and metal contaminants (as required)
- Impurity Identification & Structure Elucidation
Using advanced analytical techniques, we work closely with your team to identify and assign structural data to all relevant impurities.
- Impurity Isolation or Synthesis
For accurate quantification during final analysis, we isolate or synthesize identified impurities if required.
- GLP-Compliant 5-Batch Analysis
We conduct detailed analysis of five representative commercial batches under Good Laboratory Practice (GLP) conditions using validated analytical methods.
- Final Characterization & Reporting
We characterize all five batches along with reference standards using:
- UV, IR, and NMR Spectroscopy
- LC-MS/MS and GC-MS
This ensures traceability, reproducibility, and complete regulatory compliance.
Frequently Asked Questions (FAQs)
Why is 5-batch analysis required for agrochemical registration?
Regulatory bodies mandate 5-batch analysis to ensure consistency in the quality and composition of technical grade materials across different production batches. It forms a crucial part of your product’s safety and regulatory dossier.
What types of impurities are included in the analysis?
We analyze and report relevant impurities, significant impurities, residual solvents, toxicologically significant impurities, and metal contaminants, depending on regulatory needs and material composition.
Can Eurofins Advinus help identify unknown impurities?
Yes. We use advanced structure elucidation techniques such as NMR, LC-MS/MS, and GC-MS to identify unknown impurities and confirm their structures.
Is this service compliant with international regulatory guidelines?
Absolutely. Our 5-batch analysis is GLP-compliant and adheres to the requirements of major regulatory authorities such as the EPA, ECHA, PMRA, and others.
What support do you offer during the regulatory submission process?
In addition to generating high-quality reports, we provide technical consultation, documentation support, and clarification services to ensure your submission process is smooth and successful.
Get in touch with our agroscience experts to explore how we can support your agrochemical registration efforts with high-quality and reliable regulatory data.