Description

Etoposide Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anticancer drug Etoposide by serving as a key marker for impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The product is supplied with comprehensive analytical data to support method validation and regulatory filings.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Etoposide API and finished dosage forms.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and LC-MS techniques.
• Quality Control (QC) and Quality Assurance (QA) to monitor and control impurity levels during drug manufacturing.
• Regulatory Compliance and Submission, providing essential data for drug master files (DMFs) and regulatory dossiers (e.g., for FDA, EMA).
• Stability Studies to track impurity formation in Etoposide under various storage conditions.
• Research and Development into the degradation pathways and pharmacokinetics of Etoposide.

Basic Information

Product Name	Etoposide Impurity 4
CAS No.	101648-60-6
Molecular Formula	C29H32O13
Molecular Weight	588.56 g/mol
Synonyms	4'-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]; Etoposide EP Impurity D; Etoposide Related Compound D; Podophyllotoxin, 4'-demethyl-1-[4,6-O-[(1R)-ethylidene]-β-D-glucopyranosyl]-, (5R,5aR,8aR,9R)-; 4'-Demethylepipodophyllotoxin β-D-ethylidene glucoside; Etoposide Impurity D (EP); (5R,5aR,8aR,9R)-9-[4,6-O-[(1R)-Ethylidene]-β-D-glucopyranosyloxy]-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,5-dimethoxyphenyl)furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one
EINECS	Contact for details

Quality Control

Our Etoposide Impurity 4 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, typically determined by advanced chromatographic methods like HPLC and LC-MS. We support compliance with ICH Q3A/B, USP, and EP guidelines, and specifications can be aligned with your specific pharmacopeial or internal method requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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