Solutions for Nitrosamine Analysis

Since July 2018, the detection of nitrosamines, classified as probable human carcinogens, such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), in the API of valsartan, ranitidine, and metformin has led to the worldwide recall and discontinuation of related products. As a result, demand for nitrosamine analysis is increasing worldwide.

In December 2021, the United States Pharmacopeia (USP) published General Chapter < 1469 > Nitrosamine Impurities, as a general test method to help establish risk assessments and management strategies for nitrosamine impurities.
USP General Chapter < 1469 > has been developed in line with current scientific and regulatory approaches to ensure the appropriate control of nitrosamine impurities in APIs and drug formulation, and is intended to provide a science-based approach for eliminating or reducing their presence in pharmaceuticals.

The analysis methods in USP General Chapter < 1469 > use headspace GC-MS/MS for Procedure 2 and HPLC-MS/MS for Procedure 3. This article introduces the analysis of nitrosamines by headspace GC-MS/MS and LC-MS/MS methods.

 

Procedure 2: Quantitative Analysis of NDMA, NDEA, NDIPA, and NEIPA by headspace GC-MS/MS

 

Related Products

red solid line

GCMS-TQ8040 NX

The Shimadzu triple-quadrupole GCMS-TQ8040 NX features smart technologies to boost the efficiency of routine analytical work. It automatically determines all optimum transitions and collision energies, seamlessly incorporating them into the Smart Database Series. ​

GCMS-TQ8050 NX

The Shimadzu triple-quadrupole GCMS-TQ8050 NX is capable of performing unprecedented quantitative analyses of ultra-trace amounts, down to the femtogram level. Equipped with a new, highly efficient detector and three forms of noise-reduction technologies, the GCMS-TQ8050 NX can be an extremely important asset to industries such as pharmaceutical, food safety, forensics, and more.

LCMS-8045

Equipped with a heated ESI probe, the LCMS-8045 has the highest sensitivity in its class. The heated ESI probe, high-temperature heating block, desolvation line (DL), and drying gas, all act to promote desolvation and prevent contamination of liquid droplets inside the MS unit. This improves the robustness so reliable and highly accurate data can continue to be obtained over the long run.

 

 

LCMS-8060NX

The LCMS-8060NX is a triple quadrupole mass spectrometer with world-class sensitivity and detection speeds. It boasts increased robustness and ease-of-use, as well as Analytical Intelligence to maximize your laboratory’s output.