Description

Etoposide EP Impurity A is a specified impurity and reference standard used in the quality control of the anticancer drug Etoposide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Etoposide EP Impurity A in Etoposide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Etoposide API and formulations meet pharmacopoeial specifications (e.g., EP, USP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., CMC sections for FDA, EMA) by providing impurity characterization and control data.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity during Etoposide manufacturing.

Basic Information

Item	Detail
Product Name	Etoposide EP Impurity A
CAS No.	124151-67-3
Molecular Formula	C29H32O13
Molecular Weight	588.56 g/mol
Synonyms	4'-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]; Etoposide Impurity A; 4'-Demethylepipodophyllotoxin β-D-glucopyranoside, 4,6-O-ethylidene-; Podophyllotoxin, 4'-demethyl-1-[4,6-O-(1R)-ethylidene-β-D-glucopyranosyl]-, (1α,4α,4aβ,6aα,10β,10aα,11β)-; (5R,5aR,8aR,9S)-5,8,8a,9-Tetrahydro-9-[(4,6-O-[(1R)-ethylidene]-β-D-glucopyranosyl)oxy]-5-(3,4,5-trimethoxyphenyl)furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one
EINECS	Contact for details

Quality Control

Our Etoposide EP Impurity A is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing the results for identity, assay, purity, and related substances. Our quality protocols are designed to support compliance with cGMP, ICH guidelines, and relevant pharmacopoeial standards (EP/USP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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 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.