Services

Full pre-screening identification and quantification (>0.1% significant impurities)

  • Screening of 10 batches
  • Analysis for active ingredient quantifying vs analytical standard by HPLC and GC
  • Analysis of the impurities by HPLC and GC
  • Analysis of the manufacturing solvents

GLP 5 Batch analysis

  • Selection of the 5 batches agreed with the sponsor

  • Assay and full validation for active ingredient (specificity, linearity, recovery, precision) using HPLC methodology (HPLC UV-DAD, HPLC-QDa, UHPLC UV-DAD)

  • Quantification and confirmation of the active ingredient by techniques such as IR, MS, NMR, UV and retention time

  • Assay and full validation for 3 significant impurities 0.1% (specificity, linearity, recovery, precision, LOQ, LOD) using HPLC methodology (HPLC UV-DAD, HPLC-QDa) or gas methodology (GC-MS, GC-FID)

  • Quantification vs impurity reference standards and confirmation of the identity by different techniques (MS, NMR, UV)

  • Solvent content for a maximum of 3 with full validation (specificity, linearity, recovery, precision, LOQ, LOD) using GC methodology

  • Water content analysis for 5 batches using Karl Fischer methodology

Physical-chemical characteristics

  • Physical state, color, odor
  • pH, acidity and alkalinity
  • Bulk density
  • Specific gravity and density
  • Flammability
  • UV/VIS absorbance
  • Partition coefficient (n-octanol/water)
  • Hydrolysis as a function of pH
  • Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using HPLC
  • Water solubility
  • Water content by Karl Fischer
  • Solubility in organic and nonorganic solvents
  • Identification by IR
  • Chemical Incompatibility (oxidation and reduction characteristics)
  • Dissociation Constant
  • Emulsion stability and re-emulsification
  • Insolubles in NaOH
  • Wettability
  • Persistent foam
  • Suspensibility and flowability
  • 14-day stability testing storage at 54 °C
  • Stability to metals and metal ions
  • Accelerated stability test
  • Cold stability
  • Suitability of packaging materials.
  • Real-time testing stability study for 2 years

Tailor-made studies and reports

  • Other FAO or sponsor requested tests depending on the active ingredient
  • Specific requirements for target markets like 3D Plot scan for Brazilian authorities for 5 batches
  • Full compliance report for EPA, EU, ANVISA, APVMA, EFSA, REACH amongst others… including full details of methods, assay results, spectra and chromatograms
  • Archive of GLP reports and documentation

Co-formulants

  • Identification, analysis, quantification and validation of the co-formulants by HPLC-DAD or GC-MS