Description

Entecavir Impurity 3 is a specified, high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the antiviral drug Entecavir by enabling the accurate identification and quantification of related substances during pharmaceutical development and manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Entecavir Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating sensitive analytical methods such as HPLC and LC-MS in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity profiling data required for drug approval.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Entecavir formulations.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this impurity during Entecavir manufacturing.
• Quality Control Testing: Routinely used in in-process control (IPC) and release testing of Entecavir batches to ensure compliance with strict pharmacopeial purity specifications.

Basic Information

Item	Details
Product Name	Entecavir Impurity 3
CAS No.	1391053-94-3
Molecular Formula	C12H15N5O3
Molecular Weight	277.28 g/mol
Synonyms	Entecavir Related Compound 3; BMS-200475 Impurity 3; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one; (1S,3R,4S)-2-Amino-9-[4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1H-purin-6(9H)-one; Entecavir EP Impurity C; Entecavir USP Impurity 3
EINECS	Contact for details

Quality Control

Our Entecavir Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with pharmaceutical reference standard requirements. We support compliance with ICH guidelines and major pharmacopeias (USP, EP).

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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