REGULATORY AFFAIRS SERVICES
PHYSICAL AND CHEMICAL PROPERTIES
During product development and before numerous other studies can be completed, properties of an active
substance or formulated product need to be determined. These properties range from the physical state of the
product to the detailed determination of key characteristics. The basic physical, chemical, and technical properties
of active substances and formulated products are a specific requirement for registration of all products in
accordance with regulatory frameworks. The particular data set presented varies depending on the chemistry,
nature, and intended use of the product.
© SGS Group Management SA – 2012 – All rights reserved - SGS is a registered trademark of SGS Group Management SA
The SGS regulatory team have many
years of experience in all aspects of the
regulatory process and within all specific
areas required for dossier preparation.
Using either SGS’s own fully equipped
state of the art laboratories or through
excellent links with numerous top quality
laboratories, SGS can commission and
monitor any required studies to resolve
data gaps quickly and efficiently. Core
data sets for agrochemical products
will be generated to GLP standard. Our
experts have the knowledge to ensure
that data packages are robust and
conducted to the highest standards.
Through our connections with various
regulatory authorities and through our
network of country experts SGS can
ensure compliance with any specific
local requirements.
SGS SERVICES
FOR ACTIVE SUBSTANCES:
• Description of physical state, colour
and odour
• Melting / freezing / solidification /
boiling points
• Relative density
• Vapour pressure / volatility (Henry’s
Law Constant)
• Spectra (UV / VIS, IR, NMR, MS) &
molecular extinction
• Solubility in water
• Solubility in organic solvents
FOR FORMULATED PRODUCT:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
• Partition coefficient (n-octanol / water
partition)
• Stability in water:
• Hydrolysis rate (DT50)
• Phototransformation
• Identity of breakdown products
• Dissociation constants (pKa
values)
• Flash point / flammability / autoflammability
• Explosivity / oxidising properties
• Surface tension
• pH
• Storage stability
SGS IS THE WORLD’S LEADING INSPECTION, VERIFICATION, TESTING AND
CERTIFICATION COMPANY.
Physical state / colour / odour
Explosivity / oxidising properties
Flash-point / flammability
pH / acidity or alkalinity
Viscosity / surface tension
Relative density / bulk density
Storage stability / shelf-life
Suspensibility
Spontaneity of dispersion
Dilution stability
Emulsifiabilty
Stability of emulsions
Sieve test
Size distribution of particles
Dust content
Friability / attrition characteristics
Flowability / dustability
Compatibility in tank mixes
WHY SGS
• Cost effective solutions
• State-of-the-art facilities
• Storage stability of formulated
products
• Miscibility and tank mixes
• Flocculation testing
To contact us:
E: [email protected]
www.sgs.com/SeedAndCrop