Description

Entecavir Impurity 5 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. 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 identification and quantification of Entecavir Impurity 5 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine testing in pharmaceutical QC laboratories to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to determine drug shelf life.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemical behavior of the Entecavir molecule.

Basic Information

Item	Detail
Product Name	Entecavir Impurity 5
CAS No.	84868-56-4
Molecular Formula	C12H15N5O3
Molecular Weight	277.28 g/mol
Synonyms	9-[(1S,3R,4S)-4-Hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]guanine; (1S,3R,4S)-9-[4-Hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]guanine; BMS-200475 Impurity; Entecavir Related Compound; Entecavir EP Impurity; Entecavir USP Impurity; Guanosine analog impurity
EINECS	Contact for details

Quality Control

Our Entecavir Impurity 5 is manufactured under strict quality systems to meet the exacting standards of the pharmaceutical industry. Each batch is characterized and tested using validated analytical methods, including HPLC, NMR, and MS, to ensure high purity and correct structural identity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, assay, and impurity profile. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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