Detection and quantitation of process-related impurities is an important part of quality control in biopharma manufacturing. Process-related impurities can significantly impact a pharmaceutical product’s quality, safety, and efficacy. These impurities may get generated during the manufacturing process, degradation, starting materials and reagents, by products, storage conditions, or contamination. If not properly detected and quantified, these impurities can lead to adverse effects on patients.

For this reason, ICH guidelines make quality by design (QbD) an essential requirement during pharmaceutical development. The ICH Q8, Q9, and Q10 outline a systematic approach to pharmaceutical development, emphasizing the critical importance of understanding product and process parameters to ensure product quality.

In this article, we discuss the challenges in the detection and quantitation of process-related impurities including nitrosamine impurities and Syngene’s capabilities and solutions to address them.