Impurity profiling and Excipient analysis

Though excipients are required for a variety of functions during manufacturing of pharmaceutical formulations including biologics and biosimilars, it is necessary to assess them for biological safety and ensure that they are tested to full monograph specifications. The formulation must also be tested for any potentially toxic impurities to increase the safety and rule out any potentially harmful effects.

At VIMTA, we offer impurity profiling and excipient analysis testing for peptides and protein therapeutics using Capillary Electrophoresis, Mass Spectrometer and HPLC methods. We also have a vast experience in conducting studies for regulatory filings for multiple products.