Nitrosamine Impurity Risk Assessment

Nitrosamine Impurity Risk Assessment – Overview

Nitrosamine impurities have gained significant attention from Regulatory authorities worldwide due to their potential health risks. Pharmaceutical companies must conduct thorough risk assessments to identify and mitigate the presence of nitrosamines in pharmaceuticals. Health Authorities such as the USFDA, EMA, MHRA, Health Canada, PMDA, and TGA have recognized the importance of addressing Nitrosamine impurities in drugs and have taken significant steps to mitigate nitrosamine risks and ensure the safety of pharmaceutical products.

Recently, the USFDA released a final guidance titled "Nitrosamines Drug Substance Related Impurities (NDSRIs)." This guidance addresses a subset of Nitrosamine impurities known as NDSRIs, which share structural similarities with Active Pharmaceutical Ingredients (APIs) in Medicinal products and often lack specific mutagenicity and carcinogenicity data for safety assessments.

The guidance focuses on predicting the mutagenic and carcinogenic potential of NDSRIs and sets recommended Acceptable Intake (AI) limits for them. It endorses the Carcinogenic Potency Categorization Approach (CPCA) to determine AI limits based on the structural features of NDSRIs. Additionally, it discusses alternative methods for justifying higher AIs, acknowledges the possibility of granting interim AIs to certain marketed products, and provides a new deadline for confirmatory testing and required changes in drug applications.

Make a note that the specifics of nitrosamine risk assessment can vary by country and Regulatory agency, and new research and data can lead to updates in risk assessments and regulations.

At Freyr, we specialize in Nitrosamine impurity risk assessment and offer a range of services to support pharmaceutical and Biotechnology manufacturers in this critical area. Our expert Regulatory team has in-depth knowledge and understanding of Regulatory guidelines, best practices, and the latest scientific advancements related to Nitrosamine impurities. We are committed to helping pharmaceutical and Biotechnology companies navigate the complexities of risk assessment, develop effective mitigation strategies, and ensure the safety and quality of your pharmaceutical products.