Description

Simeprevir Sodium is the sodium salt form of simeprevir, a potent and selective protease inhibitor. This active pharmaceutical ingredient (API) is critical for the formulation of antiviral medications targeting specific viral infections. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of advanced therapeutic agents.

Application

• Active Pharmaceutical Ingredient (API) in antiviral drug formulations.
• Research & Development for novel antiviral therapies and mechanism of action studies.
• Pharmaceutical Intermediates for the synthesis of more complex drug molecules.
• Reference Standard in analytical laboratories for quality control and method validation.
• Clinical Trial Material for investigational new drug (IND) applications.
• Biochemical Research exploring protease inhibition and viral lifecycle.

Basic Information

Product Name	Simeprevir Sodium
CAS No.	1241946-89-3
Molecular Formula	C38H47N5O7S2Na
Molecular Weight	749.93 g/mol
Synonyms	Simeprevir sodium salt; TMC435 sodium; Olysio (brand name, refers to the drug product); (1R,3aR,6aS)-2-[(2S,3R)-2-[(4-tert-Butylphenyl)sulfonyl-(2-methylpropyl)amino]-3-(methoxycarbonylamino)butanoyl]-N-[(2S,3R)-1-[(cyclopropylsulfonyl)carbamoyl]-2-ethenylcyclopropyl]-3-methyl-3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrole-1-carboxamide sodium salt; TMC 435 sodium; Simeprevir Na; Simeprevir monosodium salt
EINECS	Contact for details

Quality Control

Our Simeprevir Sodium is manufactured under strict quality systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, and impurity profiles as per validated analytical methods (e.g., HPLC, NMR). We support compliance with cGMP (current Good Manufacturing Practice) and ICH guidelines for API production.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥98.0%
Water Content (KF)	≤5.0%
Residue on Ignition	≤1.0%
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤2.0%
Heavy Metals	≤20 ppm

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