Description

Entecavir Impurity 6 is a specified organic impurity associated with the antiviral active pharmaceutical ingredient Entecavir. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Entecavir drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Entecavir bulk drug and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles throughout the drug product lifecycle.
• Quality Control & Batch Release: Used in routine QC testing to ensure Entecavir batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity, improving overall yield and purity.

Basic Information

Product Name	Entecavir Impurity 6
CAS No.	1354695-82-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Entecavir Related Compound 6; Entecavir EP Impurity G; Entecavir USP Impurity; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one Impurity; Baraclude Impurity 6; BMS-200475 Impurity 6
EINECS	Contact for details

Quality Control

Our Entecavir Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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