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Nitrosamine data sharing

Sharing analytical data on the levels of nitrites in common excipients, reagents and solvents, and mutagenicity data on structurally-complex nitrosamines

The presence of N-nitroso-dimethylamine (NDMA) found in valsartan, an angiotensin II receptor blocker (ARB) used to treat high blood pressure, initiated an EU-wide review to assess the risk of valsartan-containing medicines.

This recall was subsequently extended to cover all sartan medicines containing a tetrazole ring as part of their structure. The following year, another EU review was initiated to examine ranitidine-containing medicines, which altogether led to the European Medicines Agency (EMA) and other regulatory authorities requesting that all Marketing Authorization Holders (MAHs) perform a risk analysis for the potential presence of nitrosamines.

As such, nitrosamine risk assessment and control have become an integral part of pharmaceutical drug product development and quality evaluation.

Our solution

We offer the Vitic Nitrites and Vitic Complex Nitrosamines data sharing initiatives to aid in impurity assessment for the risk of nitrosamines.

VITIC Nitrites LOGOS

The Vitic Nitrites data sharing initiative discusses sharing data on levels of nitrites in common excipients, reagents and solvents. This initiative can support you in compiling assessments for risk of nitrosamine formation in drug products.

Key highlights

Store and share validated nitrites and nitrites in excipient data
Contribute towards a comprehensive and robust dataset to support more scientifically driven risk assessments, aiding data and knowledge sharing among pharmaceutical companies, and enabling more informed decision making.

Streamline your workflow
Access to this large database will help to refine internal processes, minimise the need to carry out drug product testing and streamline your workflow by using nitrites and nitrites in excipient data to support multiple risk assessments.

Help reduce nitrite levels in finished drug product formulations
Within a consortium of experts, we aim to increase our understanding of the overall risk of nitrosamine formation in cases where the product contains vulnerable amines.

VITIC COMPLEX NITRO LOGOS 01 1

The Vitic Complex Nitrosamines data sharing initiative uses anonymously shared mutagenicity data on Complex Nitrosamines to improve Structure-Activity Relationships, which can help you to further understand the risks associated with your potential nitrosamine impurities.

Key highlights

Support industry progression
By participating in this consortium, you are actively supporting the progression towards more accurate predictions for this chemical class of high concern. The shared data can be used to build and validate new SAR models for the prediction of the potential mutagenic activity of nitrosamines.

Shared knowledge with other consortium members
Members of the consortium attend periodic meetings with other consortium members, allowing for discussions to be held and exchange of knowledge. Different companies face similar challenges and can learn from each other’s experiences.

Access high-quality data
Our systematic peer-review process of donated data by participating organisations within industry guarantees a high-quality dataset that you can be confident using.

Regulatory support

ICH M7

The ICH M7 guideline emphasizes safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk.

For nitrosamines, the Ames test is not currently being fully accepted to de-risk a compound. The collation of large amounts of reliable data will allow the consortium to publish SAR and other evaluations in support of the reliability of the Ames test for this critical class.

Related publications

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