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Nitrosamine Calculator

Nitrosamine Impurity Limits Calculator

Important Note

  • The Acceptance Criteria - Concentration Limit (in ppm) has been derived based on the Allowable Intake (AI) in ng/day from EMA database current as of December 1, 2024.

Terms of Use for Pharma Tools - Nitrosamine Impurity Limits

By using this tool, you agree to the following terms and conditions:

  • Usage Rights: This tool is provided for informational and educational purposes only. It is intended to assist with the calculation of dissolution profile comparisons in a basic regulatory context and is not a substitute for professional judgment or regulatory advice.
  • Accuracy: While every effort has been made to ensure the accuracy of the tool's calculations and outputs, we do not guarantee that the results are free from errors. Users are advised to independently verify any results obtained through this tool.
  • Limitation of Liability: We are not liable for any damages, losses, or consequences that may arise from the use or misuse of the tool. The tool is provided "as is" without any warranties of any kind, either express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, and non-infringement.
  • Intellectual Property: All content, design, and functionality of the "Pharma Tools" feature are the intellectual property of ISAZI Pharma and Techno Consultancy Pvt. Ltd. Unauthorized use, reproduction, or distribution of any part of the tool is strictly prohibited.
  • Privacy: The tool may collect non-personally identifiable information, including but not limited to usage data. This data will be used solely for internal purposes to improve the functionality of the tool. For more information, please contact us.
  • Modifications: We reserve the right to modify, suspend, or discontinue the tool at any time without prior notice. Any changes will be updated on this page.
  • Compliance: Users must ensure compliance with all applicable regulations and guidelines while using this tool.

By using this tool, you acknowledge that you have read, understood, and agreed to these terms and conditions.