Description

Entacapone Impurity 1 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Entacapone. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a key marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Primary use as a pharmaceutical reference standard for Entacapone.
• Critical component in HPLC and LC-MS method development and validation for impurity profiling.
• Used for quality control and batch release testing of Entacapone API.
• Essential for stability studies to monitor degradation pathways.
• Serves as a system suitability and identification marker in pharmacopoeial testing.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing impurity characterization data.
• Utilized in research and development of Entacapone synthesis and purification processes.

Basic Information

Product Name	Entacapone Impurity 1
CAS No.	100644-89-1
Molecular Formula	C14H15N3O5
Molecular Weight	305.29 g/mol
Synonyms	(E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide; (2E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylprop-2-enamide; Entacapone Nitrocatechol Impurity; Entacapone Related Compound A; OR-462 Impurity; ZT-1 Impurity
EINECS	Contact for details

Quality Control

Every batch of Entacapone Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure high purity and identity, suitable for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, purity, and identification tests performed via HPLC, IR, and other relevant analytical methods.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability.

Specification

Item	Specification
Appearance	Yellow to brownish powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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