Description

Etoposide Ep Impurity Q is a high-purity chemical reference standard critical for pharmaceutical analysis and quality control. This compound serves as a specified impurity in the development and validation of analytical methods for the anticancer drug Etoposide, ensuring product safety and regulatory compliance. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers engaged in the production of high-grade active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Etoposide API and finished drug products.
• Analytical Method Development & Validation: A critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for purity testing.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard and for preparing calibration curves in routine quality control testing to meet pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Used to monitor the formation of degradation products in Etoposide under various stress conditions (heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for generating impurity data for regulatory filings (e.g., ANDA, NDA) to comply with ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Etoposide.

Basic Information

Item	Detail
Product Name	Etoposide Ep Impurity Q
CAS No.	153975-26-9
Molecular Formula	C29H32O13
Molecular Weight	588.56 g/mol
Synonyms	Etoposide EP Impurity Q; Etoposide Related Compound Q; 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)methyl]-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 EP Imp Q; Etoposide Impurity Q (EP)
EINECS	Contact for details

Quality Control

Every batch of Etoposide Ep Impurity Q is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR, MS), to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

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 product 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.