The Importance of Nitrosamine Testing
Nitrosamines are classified as probable human carcinogens, and their presence in pharmaceutical products poses significant health risks. Since the discovery of nitrosamine impurities such as N-nitrosodimethylamine (NDMA) in various medicinal products in 2018, rigorous testing has become critical in ensuring product safety and regulatory compliance.
Pharmadox Healthcare provides comprehensive nitrosamine testing services, helping pharmaceutical companies safeguard their products and protect patient health.
Detecting harmful impurities to ensure product safety.
Nitrosamine impurities, including NDMA, have been found in several commonly used pharmaceutical products, leading to recalls and regulatory action. Due to their potential carcinogenic effects, detecting and controlling nitrosamines is essential. These impurities can be difficult to identify, which is why a robust nitrosamine testing method is crucial. Pharmadox Healthcare’s nitrosamine testing services ensure that your pharmaceutical products meet regulatory standards, protecting patients from unintended exposure to harmful substances.
Probable human carcinogens
Nitrosamines can pose serious health risks if left undetected.
Regulatory compliance
Testing is essential to meet EU, EMA, and ICH standards.
Risk management
Preventing potential contamination throughout the manufacturing process.
Advanced Nitrosamine Detection Technologies
At Pharmadox Healthcare, we use advanced technologies, including Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), to detect nitrosamine impurities with high precision. Our expertise in nitrosamine testing allows us to identify even trace amounts of impurities, ensuring that your products are safe for consumption and fully compliant with regulatory guidelines.
Utilizing the latest technologies for precise and reliable results.
GC-MS and LC-MS/MS
High-precision detection of nitrosamine impurities.
Accurate results
Identifying even trace levels of contaminants.
EU regulatory compliance
Ensuring products meet stringent EMA and ICH guidelines.
Risk Assessments and Contamination Prevention
Pharmadox Healthcare’s nitrosamine testing services go beyond detection—we also offer comprehensive risk assessments to identify potential sources of contamination within your manufacturing process. By identifying risks early, we help pharmaceutical supliers implement measures to prevent contamination and ensure product quality throughout the production lifecycle.
Proactively managing contamination risks throughout the production process.
- Risk assessments: Identifying contamination risks during manufacturing.
- Preventative solutions: Implementing controls to mitigate contamination risks.
- Maintaining product quality: Ensuring product safety throughout production.
Nitrosamine Testing for Active
Pharmaceutical Ingredients (APIs)
Our nitrosamine testing services extend to Active Pharmaceutical Ingredients (APIs), where early detection and management of impurities are crucial. By testing APIs for nitrosamine impurities, Pharmadox helps pharmaceutical manufacturers maintain product safety and quality from the initial stages of production, preventing issues before they arise in the finished product.
Ensuring impurity control from the very start.
API testing
Ensuring nitrosamine impurities are identified early.
Proactive impurity control
Maintaining safety and quality during production.
Comprehensive testing
Extending nitrosamine testing across all production stages.
Ensuring compliance, safety, and reliability for your
pharmaceutical products.
Pharmadox Healthcare is committed to providing accurate, reliable nitrosamine testing services. With advanced detection methods, risk management expertise, and a focus on regulatory compliance, we help pharmaceutical companies ensure the safety and quality of their products, protecting patients from harmful impurities.
Pharmadox Healthcare is committed to providing accurate, reliable nitrosamine testing services. With advanced detection methods, risk management expertise, and a focus on regulatory compliance, we help pharmaceutical companies ensure the safety and quality of their products, protecting patients from harmful impurities.