Description

Entacapone-3'-Sulfate Sodium Salt is a high-purity, pharmacologically relevant reference standard and synthetic intermediate. This compound is critical for analytical method development, quality control, and research in pharmaceutical development. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for impurity profiling, stability studies, and regulatory compliance of drug products containing entacapone.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and validation of Entacapone API and finished dosage forms.
• Metabolite Research: Serves as a key metabolite or degradation product reference in pharmacokinetic and drug metabolism studies.
• Analytical Method Development: Essential for developing and calibrating HPLC, LC-MS, and other chromatographic methods for impurity quantification.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) requiring characterization of potential impurities.
• Stability Testing: Employed in forced degradation studies to identify and monitor degradation pathways of entacapone-based medications.
• Process Chemistry R&D: Acts as a critical intermediate or marker in the research and optimization of synthetic routes for entacapone.

Basic Information

Product Name	Entacapone-3'-Sulfate Sodium Salt
CAS No.	158069-72-8
Molecular Formula	C14H14N2NaO7S
Molecular Weight	377.32 g/mol
Synonyms	(E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide 3'-Sulfate Sodium Salt; Entacapone 3'-O-Sulfate Sodium; Entacapone Sulfate Ester Sodium Salt; Entacapone Metabolite Sulfate Sodium Salt; COMt Inhibitor Metabolite Standard; 2-Propenamide, 2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-, 3'-(hydrogen sulfate), sodium salt (1:1); (E)-Entacapone-3'-sulfate Sodium
EINECS	Contact for details

Quality Control

Our Entacapone-3'-Sulfate Sodium Salt is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and stringent control of residual solvents and moisture content. A Certificate of Analysis (COA) detailing all specifications and test results is provided with every shipment to ensure full traceability and compliance with cGMP and ICH guidelines for pharmaceutical impurities and reference standards.

Storage

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

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits
Heavy Metals	≤ 20 ppm

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