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.

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Nitrosamine Analysis Workflow

Sample Preparation

Explore our comprehensive range of sample prep solutions for an accurate nitrosamine analysis.

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Standardization & Calibration

High-quality reference standards to ensure precise, consistent, and reliable test results in nitrosamines analysis of drug products.

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HPLC/GC Analysis

Premium-grade HPLC/GC columns and accessories, meticulously designed to facilitate the precise separation of API peaks and nitrosamines.

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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.