Description

Etoposide Ep Impurity J is a high-purity reference standard critical for the analytical profiling and quality control of the anticancer drug Etoposide. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety and regulatory compliance by accurately identifying and quantifying this specific impurity. It is primarily used in research and development, method validation, and stability studies within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Etoposide Ep Impurity J in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurities in Etoposide batches.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Quality Control (QC) and Quality Assurance (QA): Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity profiling assays.
• Regulatory Compliance and Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Research and Development: Used in R&D to study the degradation pathways and metabolism of Etoposide, aiding in the development of more stable formulations.

Basic Information

Product Name	Etoposide Ep Impurity J
CAS No.	118356-05-1
Molecular Formula	C29H32O13
Molecular Weight	588.56 g/mol
Synonyms	Etoposide EP Impurity J; 4'-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]; Etoposide Impurity J (EP); 4'-Demethylepipodophyllotoxin β-D-glucopyranoside, 4,6-O-ethylidene-; Podophyllotoxin, 4'-demethyl-1-epi-, 4,6-O-ethylidene-β-D-glucopyranoside; Etoposide Related Compound J; (5R,5aR,8aR,9S)-9-(((4aR,6R,7R,8S,8aS)-7,8-Dihydroxy-2-methyl-4,4a,6,7,8,8a-hexahydropyrano[3,2-d][1,3]dioxin-6-yl)oxy)-5-(4-hydroxy-3,5-dimethoxyphenyl)-5a,6,8,8a,9,10-hexahydro-5H-[1,3]dioxolo[4,5-g]isoquinoline-7,11-dione
EINECS	Contact for details

Quality Control

Our Etoposide Ep Impurity J is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines and relevant pharmacopoeial standards. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Residual Solvents (GC)	Complies with ICH limits

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