Impurity Analysis

Global regulatory bodies require pharmaceutical manufacturers, and contract organizations or service providers to control the presence of known and unknown impurities in drug substance and final pharmaceutical drug products. Laboratories must have the capability to identify and quantify impurities and adopt onward control strategies for them with suitable analytical techniques. This facilitates meeting regulatory requirements that protect the quality, safety and onwards supply chain of released products.

Characterizing, quantifying and monitoring pharmaceutical impurities can be challenging due to the diverse chemical nature of the analytes, complexity of sample matrices, and often extremely low or trace level detection levels necessary. Waters diverse impurity analysis solutions, including chemistry and consumables, LC and MS technologies, and enabling compliant-ready software, ensure the accurate detection and identification of unknown impurities and their routine, robust, and sensitive quantification to beyond the regulatory required levels and within the expectations of a compliant laboratory environment.