Nitrosamine Impurity Analysis
Nitrosamines are typically formed by the reaction of nitrites with secondary amines under specific conditions. In drug development and production, the formation of nitrosamines can occur through multiple pathways. During manufacturing processes, nitrite impurities may react with amine precursors to generate nitrosamines. Active pharmaceutical ingredients (APIs) may contain trace levels of nitrosamines. Additionally, certain drug substances or excipients may degrade over time to form nitrosamines. Nitrosamine impurities have become a central focus in global pharmaceutical regulation due to their potent carcinogenicity.
Protheragen Impurity specializes in providing comprehensive impurity solutions for the global pharmaceutical industry. Our mission is to deliver comprehensive support throughout the drug lifecycle (from early-stage R&D to commercial production), enabling clients to meet increasingly stringent regulatory requirements. Over the years, we have detected and analyzed nitrosamine impurities across diverse complex matrices, accumulating experience. We offer GMP-compliant nitrosamine impurity analysis services to help clients rapidly identify, characterize, and quantify nitrosamine impurities, ensuring drug safety. If you have any needs, please do not hesitate to contact us.
Our Services
At Protheragen Impurity, we rely on cutting-edge analytical technologies to precisely detect and quantify nitrosamine impurities. We can test and analyze the following nitrosamine impurities:
N-nitrosodimethylamine (NDMA)
N-nitrosomethylphenylamine (NMPA)
N-nitroso-N-methyl-4-aminobutyric acid (NMBA)
N-nitrosodiethylamine (NDEA)
N-nitrosodibutylamine (NDBA)
N-nitrosoethylisopropylamine (NEIPA)
N-nitrosodipropylamine (NDPA)
N-nitrosodiisopropylamine (NDIPA)
Others
Nitrosamine Impurity Risk Assessment
Conduct a scientific risk assessment of active pharmaceutical ingredients (API), drug product manufacturing processes, and supply chain based on ICH M7 principles to identify potential nitrosamine formation pathways and risk points.
Method Development and Validation
Our expert team develops sensitive, specific, and robust analytical methods tailored to your specific molecules and matrices. Comprehensive method validation is performed to ensure analytical accuracy and reliability.
Identification and Structural Characterization of Unknown Nitrosamine Impurities
When unknown nitrosamine impurity peaks or out-of-specification impurities are detected, advanced technologies are utilized for impurity isolation, structural elucidation, and definitive characterization.
Nitrosamine Migration Assessment in Packaging Material Compatibility Studies
Evaluate the risk of nitrosamine compounds or precursors migrating from pharmaceutical packaging materials (e.g., rubber stoppers, plastic components) into drug products. Develop and validate extractables and migration study protocols specific to packaging materials.
Our Technology
Gas chromatography-mass spectrometry (GC-MS)
Liquid chromatography-high resolution mass spectrometry (LC-HRMS)
Liquid chromatography-mass spectrometry (LC-MS)
Others
Deliverables
Detailed experimental plan and raw data
Unknown impurity identification report
Complete analysis report
Nitrosamine impurity source analysis report
Method validation report
Other data
Process of Our Services
Why Choose Us?
01
Expert Team
Our team is well-versed in the requirements for impurity analysis outlined in major global pharmacopoeias and regulations. We ensure that our method development, validation, and testing processes fully comply with regulatory standards.
02
Cutting-Edge Analysis Platform
We are equipped with a variety of high-sensitivity analytical instruments, ensuring the sensitivity and accuracy of impurity detection, thereby supporting drug development and registration.
03
Customized Services
We understand that every project is unique. We offer highly flexible and tailored service solutions, adapting to your project and budget to provide the most cost-effective services.
04
Efficient and Timely Delivery
We assign dedicated project managers with proven expertise to maintain real-time communication with you, guaranteeing streamlined project progression and prompt delivery of high-quality deliverables.