Description

Entecavir Impurity 17 (Entecavir Ep Impurity C) is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Entecavir. This compound is critical for ensuring the purity, safety, and efficacy of Entecavir, a nucleoside analogue used as an antiviral medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing in compliance with pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Entecavir Ep Impurity C in Entecavir API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure Entecavir batches meet stringent impurity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug substance and product shelf-life studies.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Used in synthetic chemistry R&D to understand and mitigate the formation pathways of this impurity during the Entecavir manufacturing process.

Basic Information

Product Name	Entecavir Impurity 17 (Entecavir Ep Impurity C)
CAS No.	2204369-23-1
Molecular Formula	C12H15N5O3
Molecular Weight	277.28 g/mol
Synonyms	Entecavir Related Compound C; Entecavir EP Impurity C; BMS-200475 Impurity; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one; Entecavir Impurity C; Entecavir Process Impurity; (1S,3R,4S)-2-Amino-9-[4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1H-purin-6(9H)-one
EINECS	Contact for details

Quality Control

Every batch of Entecavir Impurity 17 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Due to its hygroscopic nature, the container should be kept tightly sealed after each use to minimize exposure to atmospheric moisture. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
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)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
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.