Analytics & Stability Testing
Assay determination, method development and validation, stability studies, and physico-chemical data and application testing – for development, screening, and product authorisation.
In the field of analytics, BioGenius supports projects involving biocidal and plant protection products – from development through to the product dossier. The focus is on robust analytical data and documentation tailored to the formulation and the respective objectives.
Analytical Methods & Validation
We support analytical questions relating to formulations – from assay determination and method development through to method validation. Where standard approaches are not sufficient, we tailor the methodology and study design specifically to your requirements. The focus is on active substances, isomers, impurities, co-formulants, and application-related analyses. Analytics can be performed on a project basis under Good Laboratory Practice (GLP) or, as required, under NON-GLP conditions.
Method Development
Scope: Active substances, isomers, impurities, co-formulants
Techniques/methods: GC-FID/GC-MS, HPLC-UV/HPLC-MS, IC, titration, UV-VIS
Method Validation
Scope: Products, active substances, impurities, application analyses
Techniques/methods: Validation in accordance with SANCO 3030/99 incl. structured documentation
Development of Test Protocols
Scope: Defined treatments, residue and application analytics
Techniques/methods: Project-specific protocols for study conduct and evaluation
Assay Determination
Scope: Formulations, development and assessment data, documentation
Techniques/methods: Project-specific analytics to determine relevant contents
Stability Studies
Our stability studies support product authorisations, regulatory requirements, and screening investigations in early development phases. Study concepts are tailored specifically to the respective product and intended area of use.
We investigate both the physico-chemical storage stability of the product and interactions with packaging materials. In addition, tests for resistance to metals and ions can be carried out where this is relevant for product assessment.
Test Parameters and Study Setups
Our stability testing includes, among other things, the following parameters and experimental setups:
- Temperature testing from −20°C to +70°C
- Accelerated storage stability of product and packaging at
30°C, 35°C, 40°C and 54°C - Storage stability at ambient temperatures of 20°C, 25°C and 30°C
- Stability testing at low temperatures
- Optional provision of controlled humidity
- Resistance to metals and ions
- Combining stability testing with application-relevant parameters (e.g. conditions of use, material contact)
Physico-chemical Data & Application Testing
We generate physico-chemical product data as a basis for product development, authorisation, and quality assurance. The test concepts are designed to be flexible and cover a broad range of standardised and application-specific parameters.
In addition to classic basic parameters, we carry out product-specific tests in accordance with internationally recognised guidelines. We also offer application testing to assess the suitability and performance of different product forms under practical conditions.
Test Parameters and Study Setups
Our stability testing includes, among other things, the following parameters and experimental setups:
- Collection of standard physico-chemical parameters (e.g. pH, density, viscosity)
- Performance of specific test methods in accordance with international guidelines, including CIPAC, OECD, FEA
- Determination of application-relevant product properties (e.g. flow, spray, or wetting behaviour)
- Application testing for different product forms (e.g. liquids, sprays, coatings)
- Adaptation of tests to product- and application-specific requirements
- Combining physico-chemical data with application-oriented test parameters
Who is this relevant for?
Manufacturers of biocidal and plant protection products
For product lines that require analytical support and stability testing – from screening through to authorisation.
Product Development & Formulation
When assay determination, method development/validation, or physico-chemical data are needed to support the next steps.
Quality Assurance & Documentation
For traceable results and structured documentation that are robust both internally and in the authorisation context.
Regulatory Affairs & Authorisation
When analytics and stability studies serve as the basis for documentation, registration planning, or internal decision-making processes.
Julian Manderfeld
Head of Analytics
Frequently Asked Questions
Here you will find answers on analytics, method development/validation, and stability studies. If you have specific questions, you can submit a project enquiry at any time.
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Get to know BioGenius
If you are planning a project in analytics, efficacy, or authorisation, we would be pleased to discuss objectives, setup, and timelines.