Description

Etoposide Ep Impurity H is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and analytical validation of the anticancer drug Etoposide, ensuring product safety and regulatory compliance. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical manufacturing and contract research organizations (CROs).

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Etoposide Ep Impurity H in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Etoposide analysis.
• Stability Studies and Forced Degradation: Employed in studies to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate thorough impurity control and characterization of the drug substance.
• Quality Control (QC) Testing: Used in routine QC laboratories as a system suitability standard and for calibrating instruments to ensure accurate impurity detection limits.
• Academic and Clinical Research: Supports investigative studies on the metabolism, pharmacokinetics, and degradation pathways of Etoposide and related compounds.

Basic Information

Product Name	Etoposide Ep Impurity H
CAS No.	102306-95-6
Molecular Formula	C29H32O13
Molecular Weight	588.56 g/mol
Synonyms	Etoposide EP Impurity H; Etoposide Impurity H; 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]-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,5-dimethoxyphenyl)furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one; Podophyllotoxin derivative
EINECS	Contact for details

Quality Control

Our Etoposide Ep Impurity H is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and control of related substances, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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