Description

Entacapone Impurity 2 (Entacapone EP Impurity B) is a specified impurity used in the quality control and analytical development of the active pharmaceutical ingredient (API) Entacapone. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference standard in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Entacapone Impurity 2 in Entacapone API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Entacapone API batches comply with pharmacopeial limits (e.g., EP, USP) for specified impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings (e.g., FDA, EMA) to demonstrate product quality and control strategy.
• Research & Development: Utilized in synthetic chemistry R&D to understand and control the formation pathways of this impurity during the API synthesis process.

Basic Information

Product Name	Entacapone Impurity 2 (Entacapone EP Impurity B)
CAS No.	116314-52-4
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 Impurity B; Entacapone Related Compound B; Entacapone Nitrocatechol Impurity; COMTr Inhibitor Impurity; OR-486 Impurity
EINECS	Contact for details

Quality Control

Our Entacapone Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting its use in GMP/GLP environments for regulatory compliance.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	Yellow to brownish-yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.2%

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