In Nitrosamine Testing, Our Quality Protects Yours
Nitrosamines in Pharmaceuticals
The pharmaceutical industry heightened its concern about nitrosamines, particularly N-nitrosodimethylamine (NDMA), after its discovery in valsartan in July 2018. This triggered recall of angiotensin II receptor blocker medications, leading to increased scrutiny for nitrosamine impurities in drug products. Multiple factors, including degradation processes, contaminated raw materials, solvents, and reagents, contribute to the presence of these "unintended" organic impurities in pharmaceuticals.
Classified as Class 1 impurities, these N-nitrosamines are designated as "cohort of concern" compounds and "known mutagenic carcinogens" by the ICH Guideline M7(R1). Additionally, they are classified as 2A–Probable Carcinogens by the International Agency for Cancer Research (IARC), highlighting the critical need for rigorous nitrosamines analysis in the pharmaceutical industry. The FDA’s list of nitrosamine impurities, including NDMA, NDEA (N-nitrosodiethylamine), NIEPA, NDIPA, NDBA (N-nitrosodibutylamine), and NMBA, highlights NDMA and NDEA as the most prevalent nitrosamines in drugs. Current regulatory restrictions allow only very low levels, requiring highly sensitive analytical techniques for nitrosamine detection.
We offer a comprehensive portfolio of nitrosamine testing products, supported by detailed application guidelines, ensuring reliable detection of these carcinogenic nitrosamines using LC-MS or GC-MS methodologies.
Nitrosamine Analysis Workflow
Features & Benefits:
- Unrivaled accuracy using certified nitrosamines standards.
- Enhanced performance through cutting-edge GC and HPLC columns.
- Precise analyses facilitated by our products' unparalleled sensitivity.
- Thorough analysis with comprehensive nitrosamine coverage from NDMA to NDBA.
- Seamless compatibility with your preferred techniques.
- Consistent, reproducible results maintained throughout analyses.
- Regulatory guideline adherence ensured with compliant products.
Explore our complete nitrosamine testing solutions, for sample prep, standardization, and analysis to guarantee the safety and quality of your pharmaceutical products.
Related Webinars
Impurity testing: Nitrosamine impurity analysis using GC-MS & LC-MS
Discover the essentials of nitrosamine impurity analysis using GC-MS & LC-MS following the regulatory requirements.
Analytical Testing of Nitrosamines in Drugs and Food
Explore the latest advancements and regulatory requirements in detecting nitrosamines, crucial contaminants in pharmaceuticals and food products.
Related Resources
- Application Note: N-Nitrosamines Determination in Valsartan
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
- Application Note: Quantitative Analysis of Nitrosamine Impurities by LC-MS Methods from the United States Pharmacopeia General Chapter <1469>
This application note describes the LC-MS-based quantitative analysis of known nitrosamine impurities following procedures 1 and 3 as given in USP general chapter <1469>.
- Application Note: Evaluation of Millex® Syringe Filters for Nitrosamine Impurities Testing in Pharmaceutical Drugs
An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.
- Application Guide: Nitrosamine Impurity Analysis in Pharmaceuticals
Explore high-quality products to support every stage of your HPLC and GC-based nitrosamine testing, complemented by select application notes for added guidance.
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