Controlling Excipient-Derived Impurities to Minimize Particulate Formation in Injectable Formulations
Day 1 Supply & Formulation Excellence Stage
06/10/2026 15:15 - 15:40pm
Contributors
Nandu Deorkar : Senior Vice President, Biopharma Production Research & Development - Avantor
The drug product formulation contains variety of excipients to provide specific functionalities from processing to drug substance stabilization. The particulate impurities in the drug product are typically formed over time due to generation of low level of impurities via degradation of formulation components.
These excipients can sometimes undergo degradation at a very low level and do not lose their functionality. However, these low level of degradation product can impact other attributes such as particulate formation. For example, benzyl alcohol is used as a preservative in many multidose injectable formation. The typical impurities such as peroxide and benzaldehyde lead to formation of secondary impurities that generated subvisible particles in the formulation. This presentation will illustrate formation of such impurities, characterization methodologies and control strategies. Typical compendial methods and specification are not sufficient. We have developed specific characterization tools along with process to control such impurities formation over time.