Formulation Storage Stability

We are fully equipped to conduct CIPAC, EEC and OECD testing for formulation storage stability trials. We can offer expert help in failed formulation studies with explanations as to why the material failed the associated test and guidance on how the formulation might be improved.

To address regulatory criteria for formal validation, we offer three levels of validation. The shortest reflect the Sanco guidelines, the next reflects a Europe wide validation and the third reflect a Worldwide validation reported to EPA format if required.

We offer a range of storage conditions tailored to meet your needs.

Seed Treatment Equipment/Analysis  

DNAL have a full range of seed treatment equipment to conduct the CIPAC methods, MT 194 - Adhesion to treated seeds and MT 175 - Determination of seed-to-seed uniformity of distribution for liquid seed-treatment formulations. Using our Hege 11 seed treatment apparatus and a host of specially made glassware DNAL can conduct these methods for most seed types. DNAL have a wealth of experience of applying the methods to seeds which we treat ourselves, and seed which are supplied to us in a treated or coated form. DNAL can offer UV absorbance analysis or chromatographic analysis of the seeds to generate the associated data. 

"Free" Active Ingredient in Microencapsulated Formulations 

DNAL have conducted many studies to assess the "Free" active ingredient in microencapsulated formulations. DNAL develop methodologies which are specific to the formulation to determine the Free and Total active ingredient present. This approach can then be assigned to storage stability trails 

OECD 123 Slow Stirring Octanol Water Partition Coefficient

DNAL have now introduced the latest version of Octanol Water Partition Coefficient OCED 123. This method supplements the two standard routes OECD107 Shake Flask and OECD 117 HPLC to determine the partition coefficient. This test guideline describes the slow-stirring method, which permits the determination of the 1-octanol/water partition coefficient (POW) values up to a log POW of 8.2. The partition coefficient between water and 1-octanol (POW) is defined as the ratio of the equilibrium concentrations of the pure test substance in 1-octanol saturated with water (CO) and water saturated with 1-octanol (CW). This works in parallel with the other two standard methods to extend the range of potential values.

Formulation tests we can offer include:
(This list is not exhaustive)

  • Accelerated storage
  • Acidity/Alkalinity
  • Adhesion to Seeds
  • Appearance of Sample and Packaging
  • Auto-Ignition Temperature
  • Auto Flammability
  • Boiling Point
  • Bulk Density
  • Caking 
  • Compatability 
  • Degree of Dispersion
  • Density 
  • Dilution Stability
  • Dissociation constant
  • Dry Sieve Analysis
  • Dustability 
  • Dustability 
  • Effectiveness of Cleaning
  • Effectiveness of Cleaning (In House Method)
  • Emulsifiability
  • Emulsion Stability
  • Explosivity (by Expert Statement) 
  • Flammability
  • Flammability on Contact with Water
  • Flash Point
  • Flowability 
  • Foaming 
  • Free amines in urea herbicides
  • Free Phenols
  • Freeze Thaw Index
  • Friability & Attrition
  • Hydrolysis 
  • Light testing (for BPR)
  • Loss on drying
  • Low Temperature Storage
  • Melting Point
  • Miscibility
  • Moisture content (Karl Fischer)
  • Nitrosamines by Thermal Energy Analysis (TEA)
  • Oxidising Ability
  • Oxidising Properties
  • Particle Size Analysis
  • Particle Size Analysis (Laser Diffraction or Sieve)
  • Partition coefficient in N-Octanol/water
  • pH
  • Photolysis 
  • Pourability 
  • Pour Density
  • Refractive Index
  • Relative Density
  • Seepage 
  • Solubility in organic solvents
  • Solubility in water
  • Spontaneity of Dispersion
  • Sprayability from Commercial Spray Tank (DNAL in house methodology)
  • Spray diameter
  • Surface Tension
  • Suspensibility 
  • Suspension Properties
  • Tap Density
  • Triethanolamine Insolubles
  • Trigger spray performance
  • Uniformity of Seed Distribution
  • Vacuum Drying Test
  • Vapour Pressure
  • Viscosity
  • Water Insoluble Residues
  • Wet Sieve
  • Wettability
  • Xylene Insoluble Residues


Physical Testing on Veterinary Products

  • Rafoxanide
  • Ketoprofen
  • Flavomycin
  • Salinomycin Sodium
  • Lincomycin Hydrochloride
  • Doxycycline Hyclate
  • Sulfachloropyridizine


Additional Solvents

  • Phenol
  • Acetic Acid
  • Dicyandiamide
  • Chloroform

In respect of method validation for Formulation Storage Stability Studies, we can offer validations which cover:

  1. Europe only
  2. Europe and South America (to include reporting and spectral requirements)
  3. Europe, South America and Australia (these resolve reporting, spectral linearity and recovery requirements and are conducted as a Globally Acceptable Validation

Contact us for further information about our services:

+44 (0)1322 228 783 or email us