Nitrite and Nitrate Analysis in Pharmaceutical Excipients

Introduction

Nitrites and nitrates can appear in pharmaceutical excipients, raw materials, and processing steps. If these compounds are present alongside secondary amines, they can form nitrosamines, many of which are harmful. Recent recalls and regulatory alerts have made early detection a priority for manufacturers.

Screening excipients for nitrite and nitrate content before formulation helps reduce waste, avoid batch disposal, and lower the risk of nitrosamine formation in finished products. Automated analysis provides a fast and reliable way to check incoming materials and identify samples that need closer review.

The ATNA system from Ellutia streamlines this process by combining high throughput with sensitive detection. It allows laboratories to quantify nitrite and nitrate levels in a simple workflow that suits routine screening.

The Challenge

Different batches of excipients can bring unexpected nitrite and nitrate levels

Nitrites and nitrates can appear in excipients, raw materials, solvents, and water used in pharmaceutical manufacturing. If these compounds are present with secondary amines, they can react to form nitrosamines. Many nitrosamines are harmful, which is why regulators expect manufacturers to understand how and where they might form.

Incoming materials are often the starting point. Variability between batches makes it difficult to know which ingredients carry a higher risk. Once formulation begins, any nitrite or nitrate present can lead to unwanted reactions, and the result may only be noticed when the final product is tested. At that stage the batch may need to be discarded, which increases cost and delays production.

Detecting nitrites and nitrates early helps avoid these issues. To do this effectively, laboratories need a fast, sensitive method that can screen a large number of samples and highlight materials that need further investigation.

The Solution

Measuring nitrosamines with gas chromatography and TEA 

Automated analysis provides a fast way to check nitrite and nitrate levels before formulation begins. The ATNA system from Ellutia measures both with the sensitivity needed to identify excipients that may form nitrosamines later in the process.

The system prepares and analyses calibration standards automatically, which helps maintain repeatability across large batches of samples. It can process high sample numbers without constant supervision, which suits routine screening of incoming materials.

Calibration curves for sodium nitrite and sodium nitrate can be created across a wide concentration range, and the system produces stable, repeatable responses at low levels. This gives laboratories a clear picture of which excipients carry higher risk and which can proceed to formulation with confidence.

Automated screening helps avoid wasted batches, reduces disposal costs, and gives manufacturers more control over potential nitrosamine formation. It also supports a more efficient workflow by highlighting only the samples that need closer investigation.