Description

Etoposide Impurity O is a designated impurity of the antineoplastic agent Etoposide, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical development and manufacturing to ensure the purity, safety, and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical R&D departments, and quality assurance units for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Etoposide and related substances.
• Impurity Profiling & Identification: Essential for identifying and quantifying this specific impurity during the drug development process and stability studies.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, such as HPLC and LC-MS, for Etoposide.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Used to track the formation of this impurity over time under various storage conditions to establish product shelf life.

Basic Information

Product Name	Etoposide Impurity O
CAS No.	260974-95-6
Molecular Formula	C29H32O13
Molecular Weight	588.56 g/mol
Synonyms	Etoposide Related Compound O; 4'-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside], 4'-(phosphate); 4'-Demethylepipodophyllotoxin 9-[4,6-O-ethylidene-β-D-glucopyranoside], 4'-(dihydrogen phosphate); Podophyllotoxin derivative impurity; Etoposide EP Impurity O; Etoposide USP Impurity O; (5R,5aR,8aR,9S)-9-(((4aR,6R,7R,8S,8aS)-7,8-Dihydroxy-2-methyl-4a,6,7,8a-tetrahydro-4H,5H-pyrano[3,2-d][1,3]dioxin-6-yl)oxy)-5-(4-hydroxy-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydro-5aH-furo[3',4':6,7]naphtho[2,3-d][1,3]dioxol-6(5aH)-one 4'-(dihydrogen phosphate)
EINECS	Contact for details

Quality Control

Our Etoposide Impurity O is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization by spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current pharmacopeial expectations (USP, EP) for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified 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.