Saquinavir Mesylate is the mesylate salt of saquinavir, a peptidomimetic HIV-1 protease inhibitor used as an antiretroviral pharmaceutical ingredient. The exact mesylate form has CAS No. 149845-06-7, molecular formula C₃₉H₅₄N₆O₈S, and molecular weight approximately 766.95 g/mol. PubChem identifies CAS 149845-06-7 as the monomethanesulfonate salt, while the parent saquinavir has CAS 127779-20-8.
Saquinavir inhibits HIV-1 protease, an enzyme required for the processing of viral polyproteins. By inhibiting this enzyme, saquinavir interferes with the maturation of infectious HIV particles.
The mesylate salt is the specific pharmaceutical form covered by the USP-NF monograph. USP specifies that Saquinavir Mesylate contains NLT 98.5% and NMT 101.0%, calculated on the anhydrous basis.
| Parameter | Details |
|---|---|
| Product Name | Saquinavir Mesylate |
| CAS Number | 149845-06-7 |
| Parent Saquinavir CAS | 127779-20-8 |
| Synonym | Saquinavir Monomethanesulfonate |
| Molecular Formula | C₃₉H₅₄N₆O₈S |
| Molecular Weight | 766.95 g/mol |
| Drug Class | HIV-1 Protease Inhibitor |
| Chemical Class | Peptidomimetic antiviral |
| Salt Form | Mesylate / Methanesulfonate |
| USP Assay | 98.5–101.0%, anhydrous basis |
PubChem reports a calculated molecular weight of 766.9 g/mol, while the USP monograph gives 766.96 g/mol for the defined mesylate salt.
Saquinavir Mesylate API is associated with antiretroviral formulations for HIV-1 infection. Saquinavir acts by inhibiting HIV protease and has historically been used in combination antiretroviral therapy.
Its pharmaceutical applications include:
The USP-NF monograph specifically establishes the 98.5–101.0% assay range on an anhydrous basis and identifies USP Saquinavir Mesylate RS and Saquinavir Related Compound A RS as reference standards.
Quality control for Saquinavir Mesylate should include appropriate validated procedures for:
Because Saquinavir Mesylate is a stereochemically defined, relatively complex small molecule, identity of the exact mesylate form and control of related substances are particularly important.
Pharmaceutical-grade Saquinavir Mesylate requires controlled manufacturing, validated analytical testing and documented batch-to-batch quality. The exact mesylate salt form (CAS 149845-06-7) should be clearly distinguished from free Saquinavir (CAS 127779-20-8).
Manufacturing documentation may include Certificate of Analysis, specification sheet, Safety Data Sheet, Certificate of Origin, analytical reports and applicable regulatory documentation.
Saquinavir Mesylate should be packaged in suitable pharmaceutical-grade, well-closed containers that protect the material from moisture, contamination and unsuitable environmental exposure.
Storage conditions should follow the approved product specification and stability data rather than using an unsupported universal temperature claim.
Typical pharmaceutical documentation includes:
Saquinavir Mesylate is a well-characterized antiretroviral pharmaceutical substance with an established USP-NF monograph. Its defined mesylate salt identity and USP assay range provide clear quality benchmarks for pharmaceutical manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |