Chemical-Physical properties

Chemical and physical data are required to support the approval of an active substance and the authorisation of a formulated product.
For Plant Protection Products (PPPs), Biocides and Veterinary Medicinal products (VMPs) the chemical, physical and technical characteristics, along with their shelf-life, are intended to  show the safe and effective application of these products, according to their directions of use and that, during the storage, the formulation preserves the active substance and physical-chemical characteristics.
BioTecnologie BT staff is familiar with many types of formulations:
CS, DP,  DT,  EC, EW,  FS, GR, GW, ME, OD, SC,  SE,  SG, SL, SP, ST, WG,  WP,  WT and ZC


 
Storage Stability Studies
Cold Stability Testing  (0°C) according to CIPAC MT 39.3
Accelerated Storage Stability according to CIPAC MT 46.3
Shelf Life at Room Temperature

Analytical profile of batches of technical materials and formulated products
Chemicals
The analyses of at least five representative batches of production on an industrial scale recent and current of the active substance, is necessary to determine the content of the pure active substance, impurities, additives, and any other additional component. Data reported must include the results of the analysis of individual samples and a summary of these data, showing at least the minimum, maximum and average of each significant component.
Microbial Pest Control Agents (MPCA)
The analyses of at least 5 representative batches of production, or pilote-scale batches, is necessary to determine the content of the pure active substance, microbial contaminants and pathogens.The manufacturing processes have the potential of producing unwanted micro-organisms in addition to the desired MPCA which include pathogens, their associated toxins and other metabolic by-products of health concern.
 
BioTecnologie BT's laboratories are equipped with modern intruments to do tests on different technical grade active ingredients and formulations:
Appearance Internal method-OPPTS 830.6302, 830.6303, 830.6304
Active substance/s content
pH CIPAC MT 75.3
Acidity/Alkalinity CIPAC MT 191
Viscosity OECD TG 114-CIPAC MT 192
Surface tension OECD TG 115-EC A.5
Relative density OECD TG 109-ISO 758-EC A.3
Bulk density CIPAC MT 186
Vapour pressure OECD TG 104-EC A.4
Dissociation costant in water OECD TG 112
Water solubility OECD TG 105-EC A.6
Solubility in organic solvents CIPAC MT 181
Melting ponit/melting range  OECD TG 102
Persistent foaming CIPAC MT 47.2-MT 47.3
Suspensibility CIPAC MT 184
Spontaneity of dispersion CIPAC MT 160-MT 174 
Pourability CIPAC MT148/148.1
Dissolution degree and solution stability CIPAC MT 179.1
Dilution stability of aqueous solutions CIPAC MT 41-MT 41.1
Dispersion stability CIPAC MT 180
Wet sieve test CIPAC MT 185
Dry sieve test CIPAC MT 170
Particle size distribution OECD TG 110-CIPAC MT 187
Emulsion stability, emulsifiability, re-emulsification CIPAC MT 36.3
Wettability CIPAC MT 53.3
Dustability CIPAC MT 34
Dust content CIPAC MT 171.1
Flowability CIPAC MT 172.1
Dissociation rate of water soluble bag CIPAC MT 176
Solution properties of ST formulations CIPAC MT196
Attrition-Hardness and Integrity CIPAC MT 193
Attrition resistance of granules CIPAC MT 178.2
Disintegration time (Internal method)
Adhesion to treated seeds CIPAC MT 194
Seed loading (Internal  method)
Uniformity of distribution on seeds CIPAC MT 175
Flashpoint EC A.9
Pyrophoric properties for solids and liquids EC A.13
Flammability (solids) EC A.10
Flammability (gases) EC A.11
Flammability on contact with water EC A.12
Explosive properties EC A.14
Auto-ignition temperature (liquids and gases)  EC A.15
Realtive self-ignition temperature for solids EC A.16
Oxidising properties (solids) EC A.17
Oxidising properties (liquids) EC A.21

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