Overview

Central to the international data requirements for registration of an active ingredient, 5-batch analysis is the identification and quantification of all components present in the substance as manufactured. Representative samples from five production batches, or at suitable intervals in a continuous process, are analyzed to provide information that is used to generate a product specification.

For over 20 years, Charles River chemists have developed expertise in the separation, identification, synthesis and quantification of impurities that may be present as a very small proportion of structurally similar or isometric materials.

We will work closely with you to develop a practical and cost-effective program for identifying and quantifying impurities within your production batches to obtain a successful registration.

Our expertise includes, but is not limited to:

  • Aryloxyalkanoic acids
  • Aryloxyphenoxpropionate
  • Azoles
  • Benzoic acid
  • Carbamates
  • Chloroacetamides
  • Courmarins
  • Dinitroanilines
  • Neonicotinoids
  • Organophosphates
  • Oxime carbamates
  • Pyrethroids
  • Srobilurins
  • Sulphonylyureas
  • 1,3,5-triazines
  • Triazoles
  • Ureas

Custom synthesis of identified impurities can be arranged.