Description

cis-Entacapone-3'-Sulfate Sodium Salt is a key analytical reference standard and synthetic intermediate of significant pharmaceutical importance. This compound is critical for research, development, and quality control processes related to the catechol-O-methyltransferase (COMT) inhibitor class of drugs. It is primarily utilized by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers of active pharmaceutical ingredients (APIs) for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Entacapone and related drug substances.
• Impurity Profiling & Characterization: Essential for identifying and quantifying process-related impurities and degradation products in Entacapone API batches to ensure drug safety and efficacy.
• Metabolite Studies: Serves as a critical standard in pharmacokinetic and drug metabolism studies to understand the biotransformation pathways of Entacapone.
• Method Development & Validation: Employed in the development and validation of analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS/MS assays.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of identity for specific impurities or metabolites.
• Synthetic Intermediate: Can be used in advanced research for the synthesis of novel Entacapone analogs or labeled compounds for tracer studies.

Basic Information

Product Name	cis-Entacapone-3'-Sulfate Sodium Salt
CAS No.	158069-74-0
Molecular Formula	C14H13N2NaO7S
Molecular Weight	376.32 g/mol
Synonyms	(2Z)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide 3'-Sulfate Sodium Salt; Sodium (2Z)-2-cyano-3-(4,5-dihydroxy-2-nitrophenyl)-N,N-diethylprop-2-enamide 3-sulfate; Entacapone 3'-Sulfate Sodium Salt (cis-isomer); (Z)-Entacapone-3'-Sulfate Sodium Salt; COMt inhibitor metabolite reference standard
EINECS	Contact for details

Quality Control

Our cis-Entacapone-3'-Sulfate Sodium Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and definitive identity, meeting the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity confirmation (by HPLC, MS, NMR), and impurity profile is provided with every shipment to support your regulatory and research needs.

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 kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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