Indinavir Sulfate is the sulfate salt of indinavir, a synthetic HIV protease inhibitor and active pharmaceutical ingredient used in antiretroviral therapy. It inhibits the HIV-1 protease enzyme, an essential enzyme required for the processing of viral polyproteins and production of mature infectious HIV particles.
Indinavir Sulfate has the molecular formula C36H47N5O4·H2SO4 and a molecular weight of approximately 711.88 g/mol. Its CAS Number is 157810-81-6.
Indinavir is an orally active antiretroviral agent belonging to the protease inhibitor class. The sulfate salt is used for pharmaceutical formulation because of its suitable physicochemical properties.
Indinavir inhibits HIV protease, preventing the cleavage of viral precursor polyproteins into functional structural and enzymatic proteins. This results in the production of immature, noninfectious viral particles.
Indinavir competitively inhibits the HIV-1 protease enzyme. This enzyme is required during the final stages of viral maturation.
By blocking protease-mediated cleavage of viral polyproteins, indinavir interferes with the formation of mature infectious HIV virions and thereby reduces viral replication.
Indinavir Sulfate API is used in the development and manufacture of:
Indinavir Sulfate is produced through controlled chemical synthesis followed by purification and salt formation. Pharmaceutical quality control evaluates identity, assay, related substances, residual solvents, water content and other critical quality attributes.
Indinavir Sulfate is generally supplied as a white to off-white crystalline powder. It is a hygroscopic pharmaceutical substance and should be handled under controlled environmental conditions.
Indinavir Sulfate should be stored in a tightly closed container, protected from moisture, excessive heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
Indinavir Sulfate is an HIV protease inhibitor API used in antiretroviral pharmaceutical formulations. Its inhibition of HIV-1 protease disrupts viral maturation and makes it an established component of HIV treatment regimens.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | NMT 3.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 3.0% |
| Melting Point | Approximately 150–160°C (decomposition) |