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Molnupiravir
References
FAQ's
References
- Painter, George R.; Bluemling, Gregory R.; Natchus, Michael G.; Guthrie, David, N4-Hydroxycytidine and Derivatives And Anti-Viral Uses Related Thereto, Emory University, United States, US11331331B2, October 19, 2021
- Amara, Alieu; Penchala, Sujan Dilly; Else, Laura; Hale, Colin; FitzGerald, Richard; Walker, Lauren; Lyons, Rebecca; Fletcher, Tom; Khoo, Saye, The development and validation of a novel LC-MS/MS method for the simultaneous quantification of Molnupiravir and its metabolite ss-d-N4-hydroxycytidine in human plasma and saliva, Journal of Pharmaceutical and Biomedical Analysis, Volume: 206, Pages: 114356, 2021
Frequently Asked Questions
Which solvent helps in the analysis of Molnupiravir impurities?
Methanol and DMSO are the solvents used to analyze many Molnupiravir impurities.
Are there any specific guidelines for validating analytical methods used for impurity testing in Molnupiravir?
Regulatory authorities provide guidelines for validating analytical methods used for impurity testing in Molnupiravir. These guidelines ensure the accuracy, precision, and reliability of analytical methods.
Can impurity levels in Molnupiravir vary between different manufacturers?
Molnupiravir impurity levels can vary between manufacturers as each manufacturer uses different processes or starting materials, leading to variations in impurity profiles. Regulatory standards ensure that all impurity levels meet acceptable quality criteria.
What are the temperature conditions required to store Molnupiravir impurities?
Molnupiravir impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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