Description

Entacapone Ep Impurity G is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Entacapone, a catechol-O-methyltransferase (COMT) inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing. The CAS number for this compound is 1364322-41-7.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify and quantify Entacapone Ep Impurity G in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Entacapone.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for preparing calibration curves in routine quality control testing of Entacapone API.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing data on specified impurities as per ICH guidelines.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) during drug stability testing.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemistry of Entacapone.

Basic Information

Product Name	Entacapone Ep Impurity G
CAS No.	1364322-41-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Entacapone Impurity G; Entacapone Related Compound G; (E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide Impurity; Entacapone EP Impurity G; Entacapone Nitro Isomer; Entacapone Nitrocatechol Impurity
EINECS	Contact for details

Quality Control

Our Entacapone Ep Impurity G is manufactured and tested under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with pharmacopeial standards (EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to brown powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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