Issue link: http://www.e-digitaleditions.com/i/1222740
CRO Laboratory Provides Comprehensive CMC Services for Drug Products and Specialized Capabilities for N-nitrosamines Regulatory attention on N-nitrosamines N-nitrosamines are probable human carcinogens that must be limited to very low levels in pharmaceutical products. A series of events, including voluntary product recalls that occurred in 2018 and 2019, led to greater regulatory focus on N-nitrosamine contamination for certain types of drug products. In 2018, certain hypertension angiotensin II receptor blocker drugs were vol- untarily recalled by pharmaceutical companies due to N-nitrosamine contamination including the nitrosamine N-Nitrosodi- methylamine (NDMA). This was followed by the detection of N-nitrosamines in certain ranitidine (antacid) and metformin (di- abetes) drug products in 2019. These events have led to regulatory directives for pharmaceutical companies in the U.S. and Europe to perform risk assessments for potential nitrosamine contamination in their products, including testing at-risk products. PPD Laboratories: Broad N-nitrosamines experience PPD Laboratories GMP labs in Middleton, Wisconsin and Athlone, Ireland provide N-nitrosamines test- ing for our customers on a global scale. Our GMP lab has more than seventeen years of experience with leachables N-nitrosamines testing. And, we have experience testing drug substanc- es and drug products for N-nitrosamine contamination. Our experience includes: • Method development, qualification and validation customized for the specific product matrix • Testing to inform risk assess- ments • High-throughput testing for large scale stability programs With extensive experience in GC-MS, LS-MS/MS and established platform method conditions, we can quanti- fy N-nitrosamines compounds to ≤ 1.0 ng/mL in drug matrices. We have more than 60 scientists dedicated to using their expertise to solve com- plex challenges and provide com- plete assessments for N-nitrosamines. For more information on our capabilities for N-nitrosamines please contact us at: ppdi.com/contact/ppd-laboratories. • An industry leader for: testing inhaled and intranasal drug products • Small molecules, biologics, cell and gene therapy • Analytical development and validation • Stability testing and storage • Release and quality control testing • Physicochemical characterization • Extractables and leachables analysis • Functional service partnerships (FSP) Measuring the quality and quantity of the drug and its ingredients to support chemistry, manufacturing and controls (CMC) pharmaceutical development GMP LAB PPDI.COM/CONTACT/PPD-LABORATORIES