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| Intertek ASG Laboratory, Manchester, UK
GLP Studies for NONS / REACH
Physico-Chemical Property Determination for use in Regulatory Notification
The registration provisions of REACH 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.
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, agrichemical and specialty chemicals for submissions to the EU, US (EPA) and Japanese (MITI) regulatory agencies.
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:
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- Actives
- Formulated products
- Water soluble species
- Liquids, solids and dispersions
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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
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- 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
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Further measurements include:
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- Wettability
- Persistent foaming
- Flowability
- Pourability
- Dustability
- pH measurement / acidity
- Solubility in organic solvents
- Stability in organic solvents
- Storage stability
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- Thermal stability
- Flash point
- Flammability
- Explosive properties
- Self-ignition temperature
- Oxidising properties
- Conductivity
- Redox potential
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