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
- Benzoic acid
- Oxime carbamates
Custom synthesis of identified impurities can be arranged.