Regulatory Physico-Chemical Property Determination
Intertek has a dedicated and experienced Regulatory Analysis Group, specialising in physico-chemical property determination for actives and formulations, utilising OECD, CIPAC and EPA Testing Guidelines.
Services are routinely provided to a range of industries including pharmaceutical, agrochemical and specialty chemicals for submissions to the EU, US (EPA) and Japanese (MITI) regulatory agencies.
The registration provisions of the EU REACH Regulation will replace the current EU Notification of New Substances (NONS) requirements of the 67/458/EEC Dangerous Substances Directive (DSD). The registration data required to demonstrate that a chemical product can be used safely includes detailed information on its physico-chemical properties.
The Regulatory Analysis Group provide a range of services for notification packages and general testing and are extremely experienced in analytical R&D, method development and validation of robust methods for trace analysis and quantification.
Products tested include:
- Actives
- Formulated products
- Water soluble species
- Liquids, solids and dispersions
Related Services:
Guideline physico-chemical property measurements include:
- MW determination for polymers
- Spectral data (UV/vis, IR, NMR, MS)
- Melting temperature
- Boiling temperature
- Freezing temperature
- Relative density / tap density
- Dissociation constant (pKa)
- Surface tension
- Water solubility
- Solvent solubility
- Hydrolysis as a function of pH
- Viscosity
- Vapour pressure
- Particle size and sieve test
- Partition coefficient (octanol:water)
- Immersion corrosion testing
- Stability to metals and metal ions
- NIER testing of polymers
Further measurements include:
- Wettability
- Persistent foaming
- Flowability
- Pourability
- Dustability
- pH measurement / acidity
- Solubility in organic solvents
- Stability in organic solvents
- Storage stability
- Thermal stability
- Flash point
- Flammability
- Explosive properties
- Self-ignition temperature
- Oxidising properties
- Conductivity
- Redox potential
Request more information to see how Intertek can help your organization with Regulatory Physico-Chemical Property Determination.