Description

Entecavir Impurity 32 is a designated impurity reference standard used in the analytical profiling and quality control of the antiviral drug Entecavir. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for Entecavir drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Entecavir Impurity 32 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Entecavir batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Entecavir, supporting formulation improvement.

Basic Information

Product Name	Entecavir Impurity 32
CAS No.	1415118-53-4
Molecular Formula	C12H15N5O3
Molecular Weight	277.28 g/mol
Synonyms	Entecavir Related Compound 32; 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 G; Baraclude Impurity 32
EINECS	Contact for details

Quality Control

Every batch of Entecavir Impurity 32 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines to support global regulatory requirements.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

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)	≥ 95.0%
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
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.