Description

Etoposide Ep Impurity I CAS NO 111712-42-6 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety of the anticancer drug Etoposide by serving as a key marker for related substances testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The availability of this well-characterized impurity is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used 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: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control the levels of specified impurities, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in Etoposide formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Utilized in pharmacokinetic and metabolic studies to understand the degradation pathways of Etoposide.

Basic Information

Product Name	Etoposide Ep Impurity I
CAS No.	111712-42-6
Molecular Formula	C29H32O13
Molecular Weight	588.56 g/mol
Synonyms	Etoposide EP Impurity I; Etoposide Impurity I; 4'-Demethylepipodophyllotoxin 9-[4,6-O-[(R)-Ethylidene]-β-D-glucopyranoside]; (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-β-D-glucopyranosyl]oxy]-5-(4-hydroxy-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydro-5aH-[1,3]dioxolo[4,5-g]furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one; Etoposide Isomer; Podophyllotoxin derivative impurity
EINECS	Contact for details

Quality Control

Every batch of Etoposide Ep Impurity I is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown 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.