News & Events

In this section

Instem Announces New Software Solution to Support Updated Nitrosamines Guidance

New Software Module Introduced to Support the Latest Regulatory-approved Carcinogenic Potency Categorization Approach (CPCA)

PHILADELPHIA, PA - September 28, 2023 - Instem a leading provider of IT solutions and services to the global life sciences market, has announced its latest module offering as part of the Leadscope Model Applier™ computational toxicology software solution.

The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada have recently released a major update on N-nitrosamine impurities in human medicinal products including a new approach to determining Acceptable Intake (AI) limits for N-nitrosamines. The new option is referred to as the Carcinogenic Potency Categorization Approach (CPCA) which is a decision tree that assigns an N-nitrosamine impurity to one of five potency categories based on its chemical environment. This information is used to assign an AI limit based on the potency category resulting from the nitrosamine structure.

Instem’s new Leadscope Model Applier N-Nitrosamine CPCA module will provide a seamless solution for rapidly generating the CPCA potency categories and its associated AI limits based on this latest guidance. Alongside this, the module will automatically and consistently calculate the potency category and associated AI limits in seconds without the need to manually process the detailed and complex chemistry rules, and rapidly generate reports aligned with regulatory expectations.

For further information about the new CPCA module please email  

About Instem

A global provider of leading software solutions and scientific insight services, Instem is helping clients bring their life enhancing products to market faster.

From concepts to cures, we enable organizations in the life sciences to more efficiently collect, report and submit high quality regulatory data, while offering them the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.

Across the entire drug development value chain, every day Instem solutions are meeting the rapidly expanding needs of life science organizations for data-driven decision making, leading to safer, more effective products.

Instem supports its global roster of clients through offices in the United States, United Kingdom, France, Switzerland, Japan, China, and India.

Instem’s in silico solutions enable organizations around the world to effectively unlock valuable knowledge contained in both public and proprietary sources of research data. Clients can also access well over 600,000 toxicology studies for more than 200,000 chemicals, enabling fast, accurate, defendable and regulatory-accepted predictions.

Press Contacts: 

Julie Jones, Marketing Director

Pooja Pankhania, Marketing Manager - In Silico Solutions