Description

Entacapone Ep Impurity I is a high-purity reference standard and a critical pharmaceutical impurity used in analytical research and development. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Entacapone, a catechol-O-methyltransferase (COMT) inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and quality control testing to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Entacapone API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): A critical component for developing, validating, and verifying chromatographic methods to ensure specificity, accuracy, and precision.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development (R&D): Serves as a key intermediate or impurity marker in synthetic route optimization and process chemistry research for Entacapone.

Basic Information

Product Name	Entacapone Ep Impurity I
CAS No.	1364322-42-8
Molecular Formula	C14H15N3O5
Molecular Weight	305.29 g/mol
Synonyms	(E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide; Entacapone Impurity I (EP); Entacapone Related Compound I; Entacapone Nitrocatechol Impurity; (2E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylprop-2-enamide; COMTP Inhibitor Impurity; Tolcapone Analog Impurity
EINECS	Contact for details

Quality Control

Our Entacapone Ep Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and traceability. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and analytical data, supporting compliance with current Good Manufacturing Practice (cGMP) and relevant pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	Yellow to brownish-yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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