Nitrosamine Testing

Ensuring Pharmaceutical Safety and Compliance

Nitrosamines can form during the manufacturing process of active pharmaceutical ingredients (APIs) and drug products. Because of their potential carcinogenic properties, nitrosamine impurities pose significant health risks to patients. Regulatory bodies like the FDA and EMA have set strict rules to manage these impurities. This makes nitrosamine risk assessments and testing vital for compliance and patient safety.

Regulatory Requirements for Nitrosamines

Pharmaceutical companies are required to conduct comprehensive risk assessments to identify potential sources of nitrosamine formation in their products. This involves evaluating manufacturing processes, storage conditions, and container/closure systems. Confirmatory testing using advanced analytical methods is essential to detect and quantify trace levels of nitrosamines, ensuring they remain within acceptable intake limits.

Potential Risks

• Delayed Approvals: Inadequate nitrosamine testing can delay regulatory approvals, hindering the timely launch of new products.
• Regulatory Non-Compliance: Failure to comply with federal guidelines can result in regulatory actions, including product recalls, warning letters and import bans.
• Health Risks: Undetected nitrosamine impurities can pose serious health risks to patients, including an increased risk of cancer.
• Financial Losses: Non-compliance and product recalls can lead to significant financial losses, damage to brand reputation and loss of market share.

Cambrex: Your Trusted Partner for Nitrosamine Testing

With over 40 years of industry experience, Cambrex has extensive expertise in detecting a full range of impurities, identifying potential risk factors, and ensuring your product is safe and compliant. Our innovative focus, advanced technology and collaborative approach make us the best partner for your nitrosamine testing needs.

Our capabilities include:

• Comprehensive Nitrosamine Risk Assessments: We conduct thorough evaluations to identify potential nitrosamine formation pathways in your products, ensuring compliance with regulatory standards.
• Advanced Analytical Services: We use advanced tools like GC-MS (EI and APCI sources) and LC-MS/MS tandem mass spec (QQQ and Q-TOF), which help us detect nitrosamines with high sensitivity and selectivity.
• Method Development and Validation: Our experienced scientists develop and validate customized analytical methods tailored to your specific APIs and drug product matrices.
• Effective Nitrosamine Mitigation Strategies: We can help optimize your manufacturing processes and make recommendations to inhibit nitrosamine formation, like adding antioxidants to the formulation.
• Regulatory Compliance: We follow the latest regulatory guidelines, ensuring that our methods and processes align with global regulatory standards.

Download our information sheet for more details on our nitrosamine risk assessment and testing capabilities.