Paritaprevir API is a direct-acting antiviral pharmaceutical active ingredient developed as a potent inhibitor of the hepatitis C virus (HCV) NS3/4A protease. It is also known by the development code ABT-450 and the synonym Veruprevir. FDA and PubChem records identify the anhydrous active moiety with the molecular formula C40H43N7O7S, molecular weight 765.88 g/mol, and CAS Number 1216941-48-8.
Paritaprevir contains multiple defined stereocenters and a defined geometric configuration, making stereochemical control an important aspect of API quality. FDA GSRS identifies the substance as having absolute stereochemistry, while NCATS reports 5 defined stereocenters out of 5.
For pharmaceutical development, Paritaprevir has been used as a component of combination antiviral therapy. It was incorporated into HCV treatment regimens with other direct-acting antiviral agents, including ombitasvir and ritonavir, and was also associated with dasabuvir-containing combination products. Regulatory documentation confirms that Paritaprevir drug substance was manufactured as a dihydrate, with molecular formula C40H43N7O7S·2H2O and molecular weight 801.91 g/mol.
Paritaprevir API is primarily associated with antiviral pharmaceutical development and HCV treatment formulations. Its mechanism is based on inhibition of the HCV NS3/4A protease, an enzyme required for viral polyprotein processing and replication. Regulatory and scientific records classify Paritaprevir within the HCV NS3/4A protease inhibitor group.
Paritaprevir has been incorporated into combination antiviral therapies rather than being used as a standalone conventional antiviral API. Its combination with other direct-acting antivirals was designed to provide complementary mechanisms against HCV replication. The API therefore requires careful control of chemical purity, stereochemical integrity, solid-state characteristics and degradation-related impurities.
A suitable Paritaprevir API Manufacturer in India should maintain stringent controls for identity, assay, related substances, residual solvents, water content and solid-state form. EMA assessment documentation confirms that the active-substance specification included visual appearance, identity by IR and HPLC, crystal form by XRPD, HPLC assay, impurity testing by HPLC and GC, residual solvents by GC, particle size, sulphated ash, water content and microbiological quality.
Because Paritaprevir is a stereochemically complex molecule, manufacturing and analytical procedures should control stereochemical integrity throughout synthesis, purification, crystallization and storage. Regulatory assessment specifically noted that chirality was controlled through appropriate material specifications.
The physical form is also important because Paritaprevir has been manufactured as a dihydrate drug substance. Water content, crystal form and storage conditions therefore need to be controlled according to the applicable approved API specification.
Paritaprevir API can be relevant to pharmaceutical R&D, analytical method development, reference-standard development, formulation research and antiviral drug-development programs. Analytical methods reported for Paritaprevir include HPLC-based procedures for determination in pharmaceutical formulations.
For commercial pharmaceutical use, the final specification should be established against the applicable regulatory filing, validated analytical methods and current quality requirements rather than relying on generic research-grade purity values.
A qualified Paritaprevir API Manufacturer in India should provide controlled manufacturing processes, analytical testing and appropriate documentation for pharmaceutical development and commercial requirements. Important quality documentation may include Certificate of Analysis, analytical method information, impurity profile, residual-solvent data, water-content results, stability information and applicable regulatory documentation.
Paritaprevir should be distinguished from other HCV antiviral APIs because its molecular structure, stereochemistry, hydrate form and impurity profile are specific to this active substance. The CAS Number 1216941-48-8 identifies the anhydrous Paritaprevir active moiety, while the approved drug substance may be supplied in a hydrated form.
Paritaprevir API should be stored according to the validated stability and approved drug-substance specification. Protection from inappropriate temperature, moisture and environmental exposure is important because the drug substance is a complex crystalline material and the pharmaceutical form can contain water of hydration. Specific storage conditions should therefore be based on the applicable stability data and product specification rather than a generic storage statement.
| 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% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |