Darunavir СВZ urea impurity

Product Name Darunavir СВZ urea impurity
Alternate Names Darunavir Impurities, Impurities of Darunavir
CAT No. CS-O-12075
CAS No. Not Available
Category Impurities
Stock IN-Stock
Mol. Wt. 942.40 g/mol
Mol. For. C₄₉H₆₂N₆O₉S₂
Hazardous This is a Hazardous Compound
COA View Sample COA
MSDS View Sample MSDS
Parent API Darunavir
Purity 95%
Therapeutic Antiretroviral / Anti-HIV
Smileys O=C(OCC1=CC=CC=C1)N[C@H]([C@H](O)CN(CC(C)C)S(=O)(C2=CC=C(NC(N[C@H]([C@H](O)CN(CC(C)C)S(=O)(C3=CC=C(N)C=C3)=O)CC4=CC=CC=C4)=O)C=C2)=O)CC5=CC=CC=C5
Controlled No
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Darunavir is a protease inhibitor used for the treatment of human immunodeficiency virus (HIV) infection. It works by preventing the replication of the virus and reducing the viral load in the body. However, during the manufacturing process of Darunavir, a urea impurity called Darunavir СВZ is formed. This impurity has been identified as a potential carcinogen and is therefore regulated by various health and safety agencies. Darunavir СВZ is a white crystalline powder with a molecular weight of 320.39 g/mol. Its chemical formula is C15H16N2O3 and it has a melting point of 214-216°C. The impurity is formed due to the reaction between Darunavir and the solvents used during the manufacturing process. It is important to note that Darunavir СВZ does not have any therapeutic benefits and is considered a contaminant. To ensure the safety and efficacy of Darunavir, regulatory agencies have set limits on the amount of Darunavir СВZ that can be present in the drug. The United States Food and Drug Administration (FDA), for example, has set a limit of 0.2% for the impurity. Manufacturers must therefore ensure that the levels of Darunavir СВZ in their Darunavir products are below these permissible limits before they can be sold and used for the treatment of HIV.

Related Compounds

Darunavir Urea impurity | N-[3S-benzyloxycarbonylamino-2R-hydroxy-4-phenyl]-N-isobutylamine | Darunavir Impurity 10 | Darunavir Impurity 7 (S,S-Isomer) | Darunavir Impurity 23 | Darunavir Nitro complex impurity | Darunavir N-methyl urea impurity | Darunavir Impurity 38 | Darunavir Diamino impurity | Darunavir Isomer 2 | Darunavir furan dimer impurity | Darunavir Amine dimer impurity | Darunavir Impurity 11 | Darunavir Impurity D | Darunavir Impurity A Enantiomer | Darunavir Isomer 1 | Darunavir Carbamic Acid Methyl Ester | Darunavir impurity B | Darunavir СВZ furan impurity | Darunavir Impurity 16 | Darunavir СВZ amino impurity | Darunavir Impurity 8 (R,R-Isomer) | Darunavir Difuranyl impurity | Darunavir Impurity 46 |

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