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Darunavir Difuranyl impurity

Also known as: Darunavir Impurities or impurities of Darunavir
Chemical Name Darunavir Difuranyl impurity
CAT No. CS-O-12079
CAS Registry# 1291087-81-4
Status Prompt Dispatch
Category Impurities
Mol. Wt. 703.80 g/mol
Mol. For. C₃₄H₄₅N₃O₁₁S
Hazardous This is a Hazardous Compound
COA View Sample COA

Additional Information


Controlled No
Parent API Darunavir
Therapeutic Antiretroviral / Anti-HIV
Smileys O=C(N[C@@H](CC1=CC=CC=C1)[C@H](OC(O[C@@H]2[C@@](CCO3)([H])[C@@]3([H])OC2)=O)CN(CC(C)C)[S](=O)(C4=CC=C(N)C=C4)=O)O[C@@H]5[C@@](CCO6)([H])[C@@]6([H])OC5
Hazardous Yes


Usage and description


Darunavir is a medication that is used to treat HIV infections. It is a protease inhibitor that works by preventing the virus from multiplying in the body. However, Darunavir may contain impurities that can have adverse effects on the body. One such impurity is Darunavir Difuranyl. Darunavir Difuranyl is a chemical impurity that is formed during the manufacturing process of Darunavir. It is a byproduct of the reaction between Darunavir and other chemicals used in the synthesis process. Darunavir Difuranyl is classified as a genotoxic impurity, which means that it has the potential to cause damage to DNA and may lead to cancer. The presence of Darunavir Difuranyl in Darunavir is regulated by various regulatory bodies such as the FDA and the EMA. The maximum acceptable limit for Darunavir Difuranyl is 0.15% in the final product. Manufacturers are required to monitor the levels of this impurity during the manufacturing process and take steps to minimize its formation. Patients who are prescribed Darunavir should be aware of the potential risks associated with Darunavir Difuranyl impurity. They should inform their healthcare provider if they experience any unusual symptoms such as fever, fatigue, or abnormal bleeding. In conclusion, Darunavir Difuranyl is an impurity that can be found in Darunavir and can have adverse effects on the body. Manufacturers are required to monitor its levels and patients should be aware of its potential risks.

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