Impurities in pharmaceutical products do not offer any therapeutic benefit for the patient and sometimes they are potentially toxic. Impurity level is a critical quality attribute for a drug substance or a drug product. Impurity control is one of the most important tasks in a process scale up.
Impurities can be controlled by understanding the formation, fate and purge of the impurities during the manufacturing process. They also can be controlled by setting up appropriate controls at places where they either enter or form during the manufacturing process of drug substance and/ or drug product.
Here at PCI Synthesis, we have developed various approaches to controlling impurities.
Some of the control strategies for impurities that we regularly implement at PCI Synthesis include, but are not limited to, the following:
Impurity control is an essential process in API or drug manufacturing. At PCI Synthesis, it is not only one of the most important tasks in process scale up, but is also one more element in our commitment to quality control in all aspects of the development process.