Description

Entecavir Impurity CAS NO 1333204-94-6 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of Entecavir, an antiviral medication, by enabling the accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical manufacturing and research & development laboratories focused on antiviral APIs.

Application

• Primary use as a pharmaceutical reference standard for Entecavir impurity profiling and method validation.
• Critical component in analytical research and development (R&D) for establishing impurity identification protocols.
• Used in quality control (QC) laboratories for routine testing of Entecavir active pharmaceutical ingredient (API) batches.
• Essential for regulatory compliance and submission, supporting ICH guidelines on impurity characterization.
• Serves as a calibration standard in chromatographic systems (HPLC, UPLC) for quantitative analysis.
• Applied in stability studies to monitor the formation of degradation products in Entecavir formulations.

Basic Information

Product Name	Entecavir Impurity
CAS No.	1333204-94-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Entecavir Related Compound; Entecavir Impurity Standard; Entecavir EP Impurity; Entecavir USP Impurity; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one Impurity; (1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]guanine Impurity; BMS-200475 Impurity
EINECS	Contact for details

Quality Control

Our Entecavir Impurity is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is subjected to comprehensive testing, including identity confirmation by spectroscopic methods and purity determination by advanced chromatographic techniques. A Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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