Description

Entecavir Impurity 16 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiviral drug Entecavir, a key medication for treating chronic hepatitis B virus (HBV) infection. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Entecavir drug substance and finished products.
• Method Development & Validation: Used in developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Essential for routine QC testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring compliance with ICH guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Entecavir formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough characterization of the drug substance.
• Research & Development: Used in R&D to study the degradation pathways and synthesis process of Entecavir.

Basic Information

Product Name	Entecavir Impurity 16
CAS No.	1661867-19-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Entecavir Related Compound 16; Entecavir EP Impurity J; Entecavir USP Impurity; Baraclude Impurity 16; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one Impurity; BMS-200475 Impurity 16
EINECS	Contact for details

Quality Control

Our Entecavir Impurity 16 is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data from advanced chromatographic and spectroscopic techniques. We ensure compliance with relevant pharmacopeial standards (USP, EP) and ICH Q3B guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. Handle with appropriate personal protective equipment in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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