Determination Of Nitrite Content In Pharmaceutical Products By High Performance Liquid Chromatography With Fluorescence Detection
DOI:
https://doi.org/10.48047/CU/54/01/250-259Keywords:
Nitrite; Nitrosamine impurities; Method Development; High-performance liquid chromatographyAbstract
Nitrite is present everywhere including water, solvents, and the environment. When it combines with amides and secondary amines, leads to generation of N-nitrosamines, that behave as a carcinogenic agent. During the production drug or products may have these impurities such as N-nitrosamines due to the employment of reagents, catalysts, solvents, or raw ingredients, which has amides or secondary amines groups during. Therefore, determination of nitrite content is very important at initial stage to find out the possible of Nnitrosamines. Different approaches have been used to determine the nitrite content in the various samples.
Downloads
References
Commissioner, O. of the FDA Statement on the FDA’s Ongoing Investigation into Valsartan and ARB Class Impurities and the Agency’s Steps to Address the Root Causes of the Safety Issues Available online: https://www.fda.gov/news-events/press-announcements/fda-statement-fdas-ongoing-investigation valsartan-and-arb-class-impurities-and-agencys-steps.
Möller, Matías N., et al. "Detection and quantification of nitric oxide–derived oxidants in biological systems." Journal of Biological Chemistry 294.40 (2019): 14776-14802.
Downloads
Published
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation .
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.
