Nitrosamine Impurity Analysis Applications

Applications for nitrosamine impurity analysis

Accurate nitrosamine impurity analysis is essential for ensuring pharmaceutical safety and regulatory compliance. Thermo Fisher Scientific chromatography and mass spectrometry solutions provide precise and reliable detection of small molecule nitrosamine impurities, nitrosamine drug substance-related impurities (NDSRIs), and nitrite in excipients, helping pharmaceutical companies meet stringent regulatory standards with speed and confidence.

Small molecule nitrosamine impurities

Small molecule nitrosamine impurities are a significant concern in pharmaceuticals due to their potential carcinogenicity and presence in certain drug products. These impurities can form during manufacturing, storage, or degradation, making their detection and control essential for regulatory compliance and patient safety. Global health authorities, including the FDA and EMA, have established strict limits on nitrosamine levels, requiring sensitive and reliable analytical methods for detection. Chromatography and mass spectrometry techniques enable precise identification and quantification, helping pharmaceutical companies ensure product purity and safety.

Highly sensitive and robust LC-MS/MS solution for quantitation of nitrosamine impurities in metformin drug products

This application note details a highly sensitive LC-MS/MS method for detecting and quantifying nitrosamine impurities in metformin drug products. The method, which uses both heated electrospray ionization (HESI) and atmospheric pressure chemical ionization (APCI), offers robust, reproducible results and meets regulatory guidelines set by the FDA and EMA. It enables the quantification of nitrosamine levels below acceptable daily intake thresholds, ensuring drug safety and compliance in routine screening.

Highly sensitive and robust LC-MS/MS solution for quantitation of nitrosamine impurities in metformin drug products

Nitrosamine drug substance related impurities (NDSRI)

Nitrosamine drug substance-related impurities (NDSRIs) are a critical concern in pharmaceutical manufacturing due to their potential carcinogenic risks. These impurities can form during drug synthesis, storage, or degradation, making their detection and control essential for ensuring drug safety and regulatory compliance. With increasing scrutiny from global agencies like the FDA and EMA, pharmaceutical companies must implement sensitive and robust analytical methods to identify and quantify NDSRIs. Techniques such as high-resolution mass spectrometry (HRAM) and chromatography provide precise detection, helping scientists mitigate risk and maintain product integrity.

Highly sensitive method for the determination of 12 nitrosamine impurities in multiple ARBs, the class of sartan drug formulations

This application note explores how the Thermo Scientific TSQ Altis Plus Triple Quadrupole MS and Vanquish Flex UHPLC System deliver precise, compliant, and reproducible nitrosamine analysis across multiple ARB drug products.

Highly sensitive method for the determination of 12 nitrosamine impurities in multiple ARBs, the class of sartan drug formulations

Analytical challenges and the effective management of nitrosamines: The evolving landscape of NDSRI analysis

Watch this expert-led webinar to explore nitrite in excipients, NDSRI detection methods, risk assessment strategies, and an industry-accessible database from Lhasa Limited. Gain key insights to overcome analytical challenges and ensure regulatory compliance.

NDSRIs present significant challenges, leading to batch recalls across multiple drug classes. Detecting these impurities at part-per-billion levels is complex due to matrix effects, false positives, and unclear carcinogenic risk.

Nitrite in excipients

Nitrites in pharmaceutical excipients can contribute to the formation of nitrosamines, potentially leading to contamination in drug products. Since nitrosamines like nitrosodimethylamine (NDMA) are known carcinogens, controlling nitrite levels in excipients is critical to ensuring drug safety and regulatory compliance. Detecting and quantifying nitrites in excipients helps manufacturers mitigate risks and meet strict FDA and global guidelines. Advanced analytical techniques, including chromatography and mass spectrometry, provide accurate and reliable nitrite detection, supporting the development of safer pharmaceuticals.

Determination of nitrite in pharmaceuticals

Learn how to detect and control NDMA in pharmaceuticals to meet FDA guidelines and ensure drug safety. This application note explores effective strategies for minimizing NDMA formation during manufacturing.

Determination of nitrite in pharmaceuticals

For Research Use Only. Not for use in diagnostic procedures.