Description

Entacapone Impurity 13 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Entacapone. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately monitoring and controlling impurity levels. It is primarily utilized in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Entacapone Impurity 13 in Entacapone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure impurity levels are within ICH Q3A/B regulatory limits.
• Stability Studies: Used to monitor the formation and growth of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to health authorities like the FDA and EMA.
• Pharmaceutical Research: Supports research into the synthesis, degradation pathways, and metabolism of Entacapone.

Basic Information

Product Name	Entacapone Impurity 13
CAS No.	158693-04-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Entacapone Related Compound 13; (E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide; 2-Propenamide, 2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-, (2E)-; Entacapone EP Impurity C; Entacapone Impurity C; Entacapone Nitrocatechol Impurity
EINECS	Contact for details

Quality Control

Our Entacapone Impurity 13 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including chromatographic purity and spectroscopic identification, to meet stringent internal specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results for identity, assay, purity, and related substances. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to prevent moisture ingress.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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