|
Items |
Standard |
|
Appearance |
White powder |
|
Related substance |
Any individual impurity ≤0.1% |
|
Total impurities≤0.5% |
|
|
Isomer |
≤0.15% |
|
≤0.15% |
|
|
Residue on ignition |
≤20PPM |
|
Water |
≤0.5% |
|
Residual solvents |
≤0.5% |
|
Assay |
≥98.0% |
Introduction: Dolutegravir (DTG), brand name TIVICAY, was approved by the U.S. Food and Drug Administration on August 12, 2013, as an integrase strand transfer inhibitor (INSTI) for HIV type 1. It is indicated for use in combination with other antiretroviral drugs to treat HIV-1 infection in adults and children aged 12 years and older with a body weight of at least 40 kg.
Application: Dolutegravir (GSK1349572) is an HIV integrase inhibitor with an IC50 of 2.7 nM. It is moderately effective against significant anti-Raltegravir mutants Y143R, Q148K, N155H, and G140S/Q148H.
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