Peramivir is a synthetic antiviral active pharmaceutical ingredient belonging to the neuraminidase inhibitor class. It is primarily used in the development and manufacture of medicines for influenza A and influenza B infections. Peramivir is a cyclopentane-based guanidine analogue with specific stereochemistry and is supplied pharmaceutically in its trihydrate form.
The FDA identifies peramivir trihydrate with the chemical formula C15H28N4O4 · 3H2O and molecular weight 382.45 g/mol. The anhydrous parent peramivir has a molecular weight of 328.41 g/mol. Therefore, the exact hydrate form should always be specified when documenting the API.
Peramivir works by inhibiting influenza virus neuraminidase, an enzyme required for efficient release of newly formed viral particles from infected cells. By interfering with neuraminidase activity, peramivir helps limit the spread of influenza virus within the respiratory tract.
Peramivir API is primarily associated with antiviral pharmaceutical development and influenza treatment. It is relevant to formulations intended for influenza A and B infections and to pharmaceutical research involving viral neuraminidase inhibition.
Key applications include:
The FDA-approved RAPIVAB formulation contains peramivir on an anhydrous basis and is supplied as an intravenous solution. The approved formulation contains 10 mg/mL peramivir in 0.9% sodium chloride, with a finished-product pH of 5.5–8.5. This finished-product information should not be confused with an API 1% solution specification.
Peramivir selectively inhibits influenza virus neuraminidase. Neuraminidase is a viral surface enzyme that facilitates the release of newly produced viral particles from infected cells. Inhibition of this enzyme reduces the release and spread of progeny influenza viruses.
This mechanism makes peramivir part of the neuraminidase inhibitor class of antiviral medicines, alongside other established influenza antivirals.
Peramivir is a stereochemically defined small molecule. The FDA pharmaceutical form is peramivir trihydrate, which contains three molecules of water associated with each molecule of peramivir. PubChem lists peramivir trihydrate as C15H34N4O7, with molecular weight 382.45 g/mol.
Peramivir is described by FDA clinical pharmacology documentation as stable but sparingly soluble in aqueous solutions in the neutral pH range.
Quality control of Peramivir API should confirm identity, assay, purity, hydrate state, stereochemical integrity, and other applicable critical quality attributes. Appropriate analytical procedures can include:
Because the pharmaceutical material is supplied as a trihydrate, water content and solid-state characterization can be particularly relevant to API quality.
Peramivir API manufacturing requires controlled chemical synthesis followed by purification, isolation, drying, and appropriate control of the final solid form. Manufacturing processes should control reaction conditions and process-related impurities while maintaining the required stereochemical configuration.
Final quality assessment can include identity, assay, related substances, residual solvents, water content, and appropriate physical and solid-state characterization.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |