Description

Entecavir Impurity 33 is a designated impurity standard used in the analytical profiling and quality control of the antiviral drug Entecavir. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Entecavir and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Entecavir API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Entecavir.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) to health authorities like the FDA and EMA.
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during the synthesis of Entecavir.

Basic Information

Item	Details
Product Name	Entecavir Impurity 33
CAS No.	1415118-52-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Entecavir Related Compound 33; Entecavir EP Impurity I; 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 33; BMS-200475 Impurity 33
EINECS	Contact for details

Quality Control

Our Entecavir Impurity 33 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents and moisture content. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment aligns with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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