Our nitrosamine and nitrosamide CKM offer several significant advantages over traditional methods. Firstly, our models comply with regulatory requirements, which reduces the need for costly analytical standards and streamlines the testing process. Unlike the models available in the literature, which are generally based on the worst-case scenario for NDMA and are very conservative, our validated custom models can accurately represent the chemical reactivity of your API or excipient, avoiding unnecessary step 2 testing and batch production analytical testing. Ultimately, utilizing nitrosamine and nitrosamide kinetic models can save your company time and money by accurately predicting nitrosation kinetics and ensuring compliance with regulatory requirements

Customized kinetic models play a crucial role in ensuring accurate nitrosamine impurity analysis, especially for APIs with vulnerable nitrogen, like secondary amides. For example, suppose your API has a withdrawing group around it, and the literature model predicts levels above the acceptable intake during the step 1 evaluation. In that case, our kinetic modeling service can provide a more precise prediction of nitrosation kinetics. Our models consider factors like low nucleophilicity and reactivity, which are typical of amides, to guarantee regulatory compliance and avoid expensive delays or product recalls. Contact us today to learn more about our state-of-the-art kinetic modeling service and how it can benefit your company.

The CKM is built using a series of reactions between the active pharmaceutical ingredient (API) or excipient and a nitrosating agent. The reactions are conducted at various concentrations and times, ranging from minutes to hours and days. The aim is to find the nitrosation rates that satisfy different conditions such as pH, concentration of the nitrosating agent, and vulnerable nitrogen species (VNS).

To achieve this, a genetic algorithm (GA) is employed to optimize the rate constants. Once the optimal values are obtained, they are fitted with available experimental data to ensure good agreement between the model prediction and experimental results. The resulting nitrosation kinetics model is then used to simulate longer times, such as a shelf life evaluation of up to 24 months, by solving the system of ordinary differential equations (ODEs).

In summary, the CKM is built through a combination of reactions and optimization techniques to create a predictive model of nitrosation kinetics for a given API or excipient.

We're glad to hear that you're interested in our service. To purchase our nitrosamine and nitrosamide kinetic model service, you can start by contacting us through our website or by email. Our team will be happy to provide you with more information about our service and answer any questions you may have.

Once you've decided to proceed with the purchase, we will provide you with a detailed proposal outlining the scope of the project, including timelines, deliverables, and pricing. We'll work with you to ensure that the proposal meets your specific needs and budget.

After you've reviewed and approved the proposal, we'll begin working on your project. Our team will keep you informed of the progress and provide regular updates throughout the project timeline.

When the project is complete, we'll deliver the final report, including all the necessary documentation and data, to you. We'll also provide ongoing support to help you with any follow-up questions or additional needs you may have.

In summary, to purchase our nitrosamine and nitrosamide kinetic model service, simply contact us through our website or email, review and approve our detailed proposal, and let us take care of the rest. We look forward to working with you!

Yes, the nitrosamine impurity analysis models meet all necessary requirements for regulatory acceptance, helping you avoid costly delays or rejections.

 Yes, the custom kinetic modeling of nitrosation can be accessed through our web-based SaaS ReactorSim interface, with no software installation required, making it easy and convenient to use.

Yes, our team of experts is always available to provide you with guidance and support throughout the process, ensuring that you get the best possible results and experience.