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Assessing the levels of nitrites in pharmaceutical excipients, solvents and reagents

The presence of N-Nitrosamines in drug products continues to be a global concern. The presence of nitrites in formulations and understanding the potential contribution they may have on the formation of nitrosamines in final drug products is a crucial part of nitrosamine impurity assessment.

The Nitrites data sharing initiative forms part of our efforts to support the global challenge of nitrosamine impurity assessment. The initiative supports more scientifically driven risk assessments, aiding data sharing among pharmaceutical companies and enabling more informed decision making.

Our solution

The Nitrites data sharing initiative has established a consortium. By sharing data on the level of nitrites in common excipients, solvents and reagents, consortium members can assess the variability and likelihood that a nitrate will react to form a nitrosamine.

The Nitrites database acts as a central platform to hold the data donated by pharmaceutical organisation members on the levels of nitrites in pharmaceutical drug products.

Used in this way, the Nitrites database allows members to understand the risk posed and aid in complying nitrosamines risk assessments in the drug product.

Key highlights

Access high-quality data
Data quality is crucial to the success of the initiative; data can be generated using any analytical method, provided the validation against the consortium criteria is met. This process guarantees a high-quality dataset that you can be confident using.

Enhance your risk assessment workflow
Expand your knowledge of nitrite levels present in a wide range of products using proprietary data. In addition, minimise the need to carry out drug product testing and streamline your workflow by using data to support multiple risk assessments.

Collaborate within industry
Joining the initiative also means collaborating in an industry consortium that meet regularly to discuss this topic. Work with experts on this shared challenge and discuss and agree upon the scientific direction of the initiative.

Regulatory support

Together with the industry-based consortium, we are familiarising the database with multiple regulatory authorities to share the work being carried out and the knowledge being developed. We aim to make both industry and regulators aware of this important data sharing initiative so that we can continue to positively impact the industry with shared knowledge. Join our Nitrites data sharing initiative and become part of a thought leading consortium!

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