Description

Entecavir Ep Impurity E (8-Methoxy Entecavir) is a specified impurity and degradation product of the antiviral drug Entecavir, used as a critical reference standard in pharmaceutical quality control. This compound is essential for the accurate identification, quantification, and monitoring of impurities during the development and manufacturing of Entecavir API and its formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Entecavir Ep Impurity E in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Entecavir.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., Drug Master Files, Common Technical Documents) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Entecavir.

Basic Information

Product Name	Entecavir Ep Impurity E (8-Methoxy Entecavir)
CAS No.	2349444-69-3
Molecular Formula	C14H19N5O4
Molecular Weight	321.34 g/mol
Synonyms	8-Methoxy Entecavir; Entecavir Impurity E; Entecavir Related Compound E; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one; BMS-200475 Impurity E; 8-OMe Entecavir; Entecavir EP Impurity E; Baraclude Impurity E
EINECS	Contact for details

Quality Control

Every batch of Entecavir Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
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.