Description

Etoposide Impurity B is a specified impurity of the potent chemotherapeutic agent Etoposide, used for quality control and analytical reference purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in the development and validation of analytical methods, stability studies, and regulatory compliance testing for etoposide-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Etoposide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used as a system suitability standard in routine QC testing to ensure the sensitivity and accuracy of impurity detection methods.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies (ICH Q3A/B).
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways of Etoposide and to synthesize purer batches of the API.

Basic Information

Item	Detail
Product Name	Etoposide Impurity B
CAS No.	100007-56-5
Molecular Formula	C29H32O13
Molecular Weight	588.56 g/mol
Synonyms	4'-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]; 4'-Demethylepipodophyllotoxin β-D-glucopyranoside, 4,6-O-ethylidene-; Podophyllotoxin, 4'-demethyl-1-[4,6-O-[(1R)-ethylidene]-β-D-glucopyranosyl]-, (5R,5aR,8aR,9S)-; Etoposide EP Impurity B; Etoposide Related Compound B; (5R,5aR,8aR,9S)-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 B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to ensure traceability and compliance with ICH guidelines and relevant pharmacopeial standards.

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); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (by HPLC)	≥ 95.0%
Related Substances (by HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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