• Detection of N-nitrosamines in Pharmaceutical Products

LC-MS

Detection of N-nitrosamines in Pharmaceutical Products

May 23 2023

HPLC-APCI-MS/MS is a method that combines high-performance liquid chromatography (HPLC) with atmospheric pressure chemical ionisation mass spectrometry (APCI-MS/MS) to detect and quantify N-nitrosamines in pharmaceutical products.

HPLC is a chromatographic technique that separates and identifies individual components in a mixture, while APCI-MS/MS is a mass spectrometric technique that ionises and fragments molecules to detect and identify specific compounds. Combining the two techniques allows for highly sensitive and specific detection of N-nitrosamines in pharmaceutical products.

This method involves first extracting N-nitrosamines from the pharmaceutical product using a suitable solvent. The resulting solution is then injected into an HPLC system, which separates the N-nitrosamines from other components in the sample. The separated N-nitrosamines are then ionized using APCI and the resulting ions are detected using mass spectrometry. The specificity of the method is further enhanced by using tandem mass spectrometry (MS/MS), which allows for the detection of specific N-nitrosamines with high accuracy and precision.

The HPLC-APCI-MS/MS method is highly sensitive and specific, making it an effective tool for the detection and quantification of N-nitrosamines in pharmaceutical products. Its use is now more important than ever given the recent increase in recalls due to N-nitrosamine contamination. Regulatory agencies around the world are now requiring that pharmaceutical manufacturers test their products for N-nitrosamines, and the HPLC-APCI-MS/MS method is one of the most reliable and widely accepted methods available.

In summary, the HPLC-APCI-MS/MS method is a highly sensitive and specific technique that can detect and quantify N-nitrosamines in pharmaceutical products. Given the potential health risks associated with N-nitrosamines, their detection and quantification is vital to ensure the safety and quality of pharmaceutical products, and the HPLC-APCI-MS/MS method is an important tool in this regard.


Digital Edition

Chromatography Today - Buyers' Guide 2022

December 2021

In This Edition Modern & Practocal Applications - Accelerating ADC Development with Mass Spectrometry - Implementing High-Resolution Ion Mobility into Peptide Mapping Workflows Chromatogr...

View all digital editions

Events

Analitica Latin America

Sep 26 2023 Sao Paolo, Brazil

Lab Asia 2023

Oct 10 2023 Hybrid event

MicroTAS 2023

Oct 15 2023 Katowice, Poland

ISPPP 2023

Nov 05 2023 Vienna, Austria

SETAC North America

Nov 12 2023 Louisville, KY, USA

View all events