Our Services – Agrochemicals, Biocides & Chemicals
5-batch analysis
5-Batch Analysis for the Agrochemical, Biocidal and Chemical Product Industries
CEMAS provides 5-batch analytical services to assess your product’s consistency and impurity profile. With decades of expertise, we conduct 5-batch analysis on a variety of products including agrochemicals, biocides and industrial chemicals. Our team has successfully delivered data in support of regulatory submissions to regulatory bodies such as ECHA, EFSA and EPA.
What is 5-Batch Analysis?
5-batch analysis is designed to assess consistency, purity and impurity profiles of five independent batches of the product, typically manufactured using standard production methods. The goal is to verify that your supplier’s manufacturing process delivers consistent batches and that the composition of the product is well confirmed. 5-batch analysis is designed to confirm that your product meets the quality, regulatory standards required and is a key part of the product’s safety, efficacy and compliance process.
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Key Elements of our 5-Batch Analysis Service
Pre-screening of batches in a non-GLP environment
- Generation of a chromatographic profile from which impurities can be assessed
- Identification of significant impurities
- Development of analytical methods where necessary
5-batch equivalence analysis, typically in a GLP environment
- Analytical method validation
- Active substance assay
- Relevant and significant impurity assay
- Characterisation of the TAS
- Accounting for > 98% of the TAS
Data to Support Regulatory Compliance
- Data from all five batches are compared to assess consistency.
- Any significant deviations or trends are identified and investigated.
- A comprehensive report is provided, summarising the analytical findings, batch-to-batch variations and any identified impurities.
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.
Analytical Techniques
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