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; all methods are updated to the latest version at the time of the initial quotation)

  • Accelerated storage CIPAC MT46.4
  • Acidity/Alkalinity CIPAC MT191
  • Adhesion to Seeds CIPAC MT194
  • Appearance of Sample and Packaging (In House Method)
  • Auto-Ignition Temperature EC A16
  • Auto Flammability EC A15
  • Boiling Point OECD 103
  • Bulk Density CIPAC MT186
  • Caking (In House Method)
  • Chemical Compatibility (In House Method)
  • Corrosivity UN TEST C.1
  • Dispersibility of water dispersible granules CIPAC MT174
  • Density EC A3
  • Discharge Rate FEA643
  • Discharge Rate of Aerosol Spray CIPAC MT202
  • Discharge Rate of Trigger Spray CIPAC MT201
  • Dilution Stability CIPAC MT41
  • Disintegration of Tablets CIPAC MT197
  • Dissociation constant OECD112
  • Dry Sieve Analysis CIPAC MT59
  • Dustability CIPAC MT34
  • Dust Content CIPAC MT58
  • Dustiness CIPAC MT171.1
  • Effectiveness of Cleaning (In House Method)
  • Emulsifiability CIPAC MT36.3
  • Emulsion Stability CIPAC MT183
  • Explosivity (by Expert Statement or DSC Screening)
  • Flammability EC A10
  • Flammability on Contact with Water EC A12
  • Flash Point (Pensky Martens) ASTM D 7094-04 and EEC A9
  • Flash Point (Abel Method) CIPAC MT12.1
  • Flash Point (Open Cup)
  • Flowability CIPAC MT142
  • Foaming CIPAC MT47.3
  • Free amines in urea herbicides CIPAC MT141
  • Free and Encapsulated Release CIPAC MT190.1
  • Free Phenols CIPAC MT155
  • Freeze Thaw Cycles (In House Methods)
  • Friability & Attrition CIPAC MT193
  • Hydrolysis OECD111
  • Internal Pressure FEA604
  • Light testing (for BPR)
  • Loss on drying CIPAC MT17
  • Low Temperature Storage CIPAC MT39.3
  • Melting Point OECD 102
  • Miscibility CIPAC MT23
  • Moisture content (Karl Fischer) CIPAC MT30
  • Nozzle Clogging For Aerosols and Trigger Sprays (In House Method)
  • Nitrosamines by Thermal Energy Analysis (TEA)
  • Oxidizing Properties in Solids UN Tests O1
  • Oxidizing Properties in Liquids UN Tests O2
  • Particle Size Analysis (Sieve Shaker) CIPAC MT59
  • Particle Size Analysis (Laser Diffraction) CIPAC MT187
  • Partition coefficient in N-Octanol/Water OECD117 and OECD123
  • pH CIPAC 75.3
  • Photolysis OECD316
  • Pourability CIPAC148.1
  • Pour and Tap Density CIPAC159
  • Refractive Index ASTM1218
  • Relative Density EC A3 and OCED109
  • Seepage (Visual Storage Assessments)
  • Seepage by Chromatographic Determination
  • Self-Heating Solids UN Test N.4
  • Solubility in organic solvents CIPAC MT181 and OECD105
  • Spontaneity of Dispersion CIPAC MT160
  • Sprayability from Commercial Spray Tank (DNAL in house methodology)
  • Spray diameter (In House Method)
  • Spray Pattern FEA644
  • Surface Tension EC A5 or OECD 115
  • Suspensibility of Aqueous Suspensions CIPAC MT161
  • Suspensibility Of Foaming Suspensions CIPAC MT184.1
  • Suspensibility of Water Dispersible Powders CIPAC MT177
  • Suspo-emulsion, Dispersion Stability CIPAC MT180
  • Sustained Combustibility UN Test L.2
  • Tap Density CIPAC MT33 and MT169
  • Triethanolamine Insolubles (In House Method)
  • Trigger spray performance (In House Method)
  • Uniformity of Seed Distribution CIPAC MT175
  • Vacuum Drying Test (In House Method)
  • Vapour Pressure OECD 104 and EEC A.4
  • Viscosity CIPAC MT192 or OECD 114
  • Water Insoluble Residues CIPAC MT10
  • Water Solubility MT157 and OECD105
  • Water Solubility of Water-Soluble Bags CIPAC MT176
  • Water Solubility of Water-Soluble Granules CIPAC MT179.1
  • Wet Sieve CIPAC MT185.1
  • Wettability CIPAC MT53
  • Xylene Insoluble Residues (In House Method)

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