Impurity profiling is mandatory in the manufacturing process of pharmaceutical products. The presence of impurities could affect the quality and safety of drug products posing health risks to patients due to their potentially carcinogenic or immunogenic effects. The large number and variety of potential impurities presents a significant analytical challenge for their detection, quantification, and characterization. One pertinent threat is that some potential impurities will be unknown. The identification of such impurities represents a critical analytical step in the drug development process, aiming to elucidate chemical structures of unidentified species, present above a certain significant threshold.
The capacity of identifying the molecular formula and the chemical structure of an impurity may help in understanding its formation mechanism, resulting in a broad spectrum of possibilities: determine toxicological issues, improve process purification steps, optimize synthetic pathways and select new suitable packaging.
Thanks to our solid expertise in the field, our leading experts will discuss the most relevant aspects of the regulatory framework providing also valuable insights on the analytical and toxicological requirements to identify unkwnown impurities. Up-to-date case studies will be showcased to help clients understand how to overcome the threat of unknown impurities and quantify them with high accuracy and sensitivity.