Our Services – Agrochemicals, Biocides & Chemicals
Method development and validation
Method development and validation solutions for the Agrochemical and Biocide Industries
Customised Analytical Solutions to Meet Industry Demands
Developing and validating analytical methods is often complex and labour-intensive, requiring a good understanding of current regulations, relevant chemistries and the use of appropriate instrumentation. CEMAS has experienced scientists who ensure the bespoke method development and validation solutions offered are designed to meet your specific requirements, and those of the healthcare and veterinary medicine industries. Our teams and custom-built laboratories, ensure the efficient creation of robust, reliable, and regulatory-compliant analytical methods and data, essential for drug development and approval.
What is Method Development and Validation?
Method development involves designing, optimising, and refining analytical techniques to measure the active ingredients, metabolites, impurities, degradation products, and other analytes in agrochemical and biocide matrices. Method validation ensures that these analytical methods are accurate, precise, reproducible, and robust, meeting regulatory standards.
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Our Services
At CEMAS, we offer a comprehensive suite of method development and validation services, customised to the specific needs of agrochemical and biocide manufacturers. These include:
Analytical Method Development
We work closely with you to develop new analytical methods for detecting and quantifying active ingredients, metabolites impurities, and other critical components. Whether you’re working with complex formulations, new active substances or any of the wide range of residue testing matrices, we tailor our approach to fit your specific needs.
- Active ingredient quantification
- Impurity/metabolite identification and quantification
- Degradation and stability studies
- Matrix challenges e.g., soil, water, plants
Method Optimisation
For existing methods that require refinement, we offer method optimisation services to improve performance.
- Enhancement of precision and accuracy
- Minimisation of matrix interferences
- Reduction of analysis time
Analytical Method Validation
Our method validation services ensure that your analytical methods meet regulatory and industry standards, including those set by GLP and global regulatory authorities. We validate methods to ensure they are suitable for their intended purpose, covering parameters such as:
- Accuracy and precision
- Specificity and selectivity
- Linearity and range
- Limit of detection (LOD) and limit of quantification (LOQ)
- Robustness and reproducibility
Regulatory Guidelines
We ensure that all method development and validation activities are aligned with required regulatory requirements, including those from SANCO and SANTE. We provide comprehensive documentation to support your regulatory submission process, ensuring products meet all necessary guidelines for approval.
Stability-Indicating Method Development
We specialise in developing stability-indicating methods to assess the degradation of agrochemical and biocide products under various environmental conditions. These methods are essential for determining the shelf-life and efficacy of products over time.
- Stress testing, to include temperature, humidity, light exposure
- Identification of degradation products
- Determination of product stability
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
