Nirmatrelvir - Isotope Labelled Standards
References
FAQ's
References
- Owen, Dafydd Rhys; Pettersson, Martin Youngjin; Reese, Matthew Richard; Sammons, Matthew Forrest; Tuttle, Jamison Bryce; Verhoest, Patrick Robert; Wei, Liuqing; Yang, Qingyi; Yang, Xiaojing, Nitrile-containing antiviral compounds, Pfizer Inc., United States, US11351149B2, June 7, 2022
- Zheng, Lewei; Wang, Lingqiao; Li, Dan; Xie, Chongjun; Gao, Zhiyuan; Lin, Jinsheng; Ye, Jian; Chen, Wenbin; Li, Min, Investigation of nirmatrelvir epimerization occurred in analytical sample solution by using high resolution LC-MSn, NMR, and hydrogen/deuterium exchange study, Journal of Pharmaceutical and Biomedical Analysis, Volume: 227, Pages: 115284, 2023
Frequently Asked Questions
What is the acceptable limit for Nirmatrelvir impurities?
The acceptable limit for impurities in Nirmatrelvir is determined by regulatory agencies such as the FDA, EMA, and ICH. The limit varies depending on the impurity and its potential impact on the drug’s quality, safety, and efficacy.
How are Nirmatrelvir impurities controlled during the manufacturing process of the drug?
Impurities in Nirmatrelvir are controlled during the manufacturing process by implementing good manufacturing practices (GMP) and using appropriate analytical methods for impurity identification and quantification. Purification techniques such as crystallization, distillation, and chromatography to remove impurities.
What is the genotoxic impurity in Nirmatrelvir?
A genotoxic impurity in Nirmatrelvir is an impurity that has the potential to cause genetic mutations or other genetic damage. Regulatory agencies have strict limits for the presence of genotoxic impurities in pharmaceuticals due to their potential carcinogenicity.
What are the temperature conditions required to store Nirmatrelvir impurities?
Nirmatrelvir impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).
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