Description

Entecavir Impurity 19 is a high-purity reference standard used in the pharmaceutical development and quality control of the antiviral drug Entecavir. This compound, with CAS No. 1030919-51-7, is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Entecavir Impurity 19 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used as a marker to track impurity formation and degradation pathways of Entecavir under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Aids chemists in understanding and optimizing the Entecavir synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Entecavir Impurity 19
CAS No.	1030919-51-7
Molecular Formula	C12H15N5O3
Molecular Weight	277.28 g/mol
Synonyms	2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one; Entecavir Related Compound 19; Entecavir EP Impurity I; BMS-200475 Impurity 19; (1S,3R,4S)-4-Hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl 2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl; Entecavir Process Impurity
EINECS	Contact for details

Quality Control

Our Entecavir Impurity 19 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with in-house specifications developed for pharmaceutical reference standard applications.

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. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

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

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