Description

Danoprevir (RG7227/ITMN-191) is a potent, orally bioavailable hepatitis C virus (HCV) NS3/4A protease inhibitor developed for the treatment of chronic hepatitis C infection. It delivers high target specificity and robust antiviral activity in clinical settings, supporting combination regimens with improved sustained virologic response (SVR) rates. This compound is essential for pharmaceutical R&D laboratories, contract development and manufacturing organizations (CDMOs), and regulatory reference standard providers engaged in antiviral drug development, stability testing, and analytical method validation.

Application

• Reference standard for HPLC and LC-MS/MS assay development and validation in pharmaceutical quality control labs
• Active pharmaceutical ingredient (API) intermediate in the synthesis of next-generation HCV protease inhibitors
• Clinical trial material for Phase I–III studies evaluating novel direct-acting antiviral (DAA) combinations
• Stability-indicating impurity reference for forced degradation studies (oxidation, hydrolysis, photolysis)
• Calibration standard for pharmacokinetic and bioanalytical quantification in human plasma and tissue matrices
• Tool compound in mechanistic virology research to study NS3/4A protease inhibition kinetics and resistance profiling
• Raw material for GMP-compliant API manufacturing under ICH Q5, Q7, and Q11 guidelines
• Comparator substance in regulatory submissions (FDA, EMA, PMDA) requiring certified reference materials (CRMs)

Basic Information

Product Name	Danoprevir (RG7227/ITMN-191)
CAS No.	924302-43-2
Molecular Formula	C37H42F3N5O6S
Molecular Weight	758.83 g/mol
Synonyms	Danoprevir; RG7227; ITMN-191; (3R,4S)-N-[(1S)-3-Cyclohexyl-1-[(2,2-difluoroethyl)carbamoyl]propyl]-4-(4-fluoro-3-{[(2-methoxyethyl)amino]carbonyl}phenyl)-3-hydroxy-1-(phenylsulfonyl)azepane-2-carboxamide; NS3 Protease Inhibitor Danoprevir; Danoprevir sodium salt (for solubility studies); GSK-2268482 (development code); CAS 924302-43-2
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches are tested per ICH Q2(R2) guidelines for identification, assay, related substances, residual solvents, and heavy metals. Testing includes HPLC purity determination, chiral purity assessment, residual moisture (Karl Fischer), and elemental impurity screening (ICP-MS). Complies with USP General Chapter <1086> Reference Standards and meets requirements for use as a primary reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (nitrogen or argon) to prevent oxidation and moisture uptake. Due to its hygroscopic nature, maintain relative humidity below 30% during storage and handling. Avoid repeated exposure to ambient air and temperature fluctuations.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.5% – 101.0%
Related Substances	≤ 1.5% total impurities; individual unknown ≤ 0.2%
Residual Solvents (GC)	Meets ICH Q3C limits (e.g., methanol ≤ 3000 ppm, dichloromethane ≤ 600 ppm)
Water (KF)	≤ 0.5%
Heavy Metals	≤ 10 ppm
Optical Rotation	[α]D20 = −22.5° to −24.5° (c = 1.0 in methanol)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.