Description

Entacapone Impurity 4 is a specified impurity and reference standard used in the quality control of the active pharmaceutical ingredient (API) Entacapone. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product, which is used in the treatment of Parkinson's disease. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Entacapone Impurity 4 in Entacapone API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating chromatographic methods to monitor impurities during stability studies.
• Quality Control & Batch Release Testing: Employed in routine quality control laboratories to ensure API batches comply with pharmacopeial (e.g., USP, EP) and internal impurity specifications.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Aids in process chemistry research to understand and minimize the formation of this impurity during the synthesis of Entacapone.

Basic Information

Product Name	Entacapone Impurity 4
CAS No.	1202160-40-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Entacapone Related Compound 4; Entacapone Impurity D; (E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide Impurity; 2-Propenamide, 2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-, (2E)-; Entacapone EP Impurity D; Entacapone USP Impurity 4
EINECS	Contact for details

Quality Control

Our Entacapone Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, NMR), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results and confirming compliance with stated specifications.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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