Our Services – Agrochemicals, Biocides & Chemicals
5-batch analysis
5-Batch Analysis for Agrochemicals, Biocides and Chemical Products
Regulatory studies supporting technical material characterisation and impurity profiling
CEMAS provides GLP and non-GLP 5-batch analysis services for agrochemicals, biocides and chemical products, generating high-quality analytical data to support global regulatory submissions. By characterising representative production batches, these studies help establish technical specifications, demonstrate manufacturing consistency and provide an understanding of impurity profiles.
Our experienced scientists work with clients throughout the study lifecycle, delivering tailored analytical programmes and regulatory-ready reports suitable for submission to authorities including ECHA, EFSA and EPA.
Why is 5-Batch Analysis Required?
5-batch analysis is a key element of many regulatory programmes and is used to demonstrate the composition and consistency of technical materials. The resulting data are used to establish specifications and support the assessment of impurities associated with the active substance.
Studies may be required for:
- Plant protection product registrations
- Biocidal active substance approvals
- Technical equivalence assessments
- New manufacturing sources
- Process changes and specification setting
- Global regulatory submissions
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Analytical Support Tailored to your Product
Every substance presents different analytical challenges. Our scientists design study programmes based on the chemistry of the material and the requirements of the relevant regulatory framework.
Active Substance Assay
Determination of active ingredient content using validated analytical methods to confirm consistency between production batches – Find out more about what we offer for agrochemicals and biocides.
Impurity Characterisation
Identification and quantification of specified, relevant and unknown impurities to provide a comprehensive understanding of the composition of the technical material – Find out more.
Trace-Level Analysis
Sensitive determination of low-level constituents and contaminants across a range of complex matrices.
Structural Elucidation
Application of advanced analytical techniques to investigate and identify unknown components where required.
Method Development and Validation
Development and validation of robust analytical procedures to ensure reliable, reproducible and regulatory-compliant data – Find out more.
Supporting Physico-Chemical Characterisation
Generation of additional analytical data to complement wider product chemistry programmes – Find out more.
Supporting Technical Equivalence Assessments
Data generated during 5-batch studies frequently form part of technical equivalence assessments and product specification packages. We support clients requiring analytical information for:
- Alternative manufacturing sources
- Process modifications
- Supplier changes
- Bridging studies
- Specification development
- Global registration programmes
Our team works closely with clients to ensure study designs align with the expectations of regulatory authorities and the requirements of individual submissions.
GLP and Non-GLP Studies
CEMAS offers both GLP and non-GLP studies depending on the intended use of the data. From study design and method development through to interpretation and final reporting, our scientists provide practical support to help clients generate scientifically robust and defensible datasets.
CEMAS’ Impurity Testing Services
Find out more about Contamination & Impurities
We can identify and quantify impurities present in your products. Our profiling services include:
- Organic Impurities: Detection of process-related and degradation-related organic compounds.
- Inorganic and Elemental Impurities: Comprehensive testing for inorganic salts and trace elements using advanced techniques including IC and ICP-MS.
Instrumental Capabilities
Our laboratories are equipped with the latest technologies and infrastructure, including:
- Liquid chromatography
- U/HPLC-MS/MS
- SFC-LC-MS/MS
- Differential Mobility Separation
- HPLC-UV, ELSD, DAD, RI, fluorescence
- Gas chromatography
- GC-ECD, FID, NPD
- GC-MS
- Headspace
- Thermal desorption
- Ion Chromatography
- ICP-MS
- FT-IR spectrometer
- Autotitrators
- Thermospectronic UV Spectrometer
Why choose CEMAS?
Science
Our scientists and study directors bring decades of experience and expertise
Compliance
GLP, GCP and GMP compliance to ensure that your regulatory needs are met
Delivery
Flexibility and responsiveness to your requirements, to provide quality data on time
Reliability
Quality and delivery are at the heart of all we do