Description

Simeprevir CAS NO 923604-59-5 is a potent and selective protease inhibitor specifically designed to target the hepatitis C virus (HCV). This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacture of effective antiviral therapies. It is primarily utilized by pharmaceutical companies and research institutions engaged in antiviral drug development, formulation, and clinical studies targeting chronic HCV genotype 1 infection.

Application

• Pharmaceutical API: Core active ingredient in the formulation of antiviral medications for the treatment of chronic Hepatitis C Virus (HCV) infection, particularly genotype 1.
• Drug Development & Research: Critical compound for preclinical and clinical research programs focused on novel antiviral therapies and combination regimens.
• Reference Standard: Serves as a high-purity analytical reference standard for quality control (QC) and research and development (R&D) laboratories to ensure product identity and potency.
• Formulation Studies: Used in the development of various dosage forms, including oral tablets and capsules, to optimize bioavailability and stability.

Basic Information

Item	Details
Product Name	Simeprevir
CAS No.	923604-59-5
Molecular Formula	C38H47N5O7S2
Molecular Weight	749.94 g/mol
Synonyms	Simeprevir; TMC435; Olysio; (1R,3aR,6aS)-2-[(2S)-2-[[(2S,5S)-1-[(2S)-2-[[(2S,3S)-1-[(2R)-2-Hydroxy-2-cyclohexylacetyl]-2-methylazetidin-3-yl]carbamoyl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]amino]-3,3-dimethylbutanoyl]-N-[(2S)-1-[(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]-3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrole-1-carboxamide; TMC 435; TMC-435; TMC 435350; TMC-435350
EINECS	Contact for details

Quality Control

Our Simeprevir is manufactured under strict quality systems to ensure it meets the stringent requirements for pharmaceutical use. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via advanced techniques like HPLC and NMR. A Certificate of Analysis (COA) documenting full compliance with specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/IR)	Conforms to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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