Description

Epirubicin Ep Impurity G is a specified impurity of the anthracycline chemotherapeutic agent Epirubicin, used for analytical reference and quality control purposes. 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 and validation.

Application

• Primary use as a pharmaceutical reference standard for Epirubicin impurity profiling.
• Critical component in analytical method development and validation (HPLC, LC-MS) for drug substance and product testing.
• Essential for quality control and stability studies to monitor impurity levels in Epirubicin API and formulations.
• Used in regulatory compliance and submission to meet ICH guidelines for impurity identification and qualification.
• Serves as a research tool in pharmacokinetic and metabolic studies of Epirubicin.
• Supports GMP manufacturing processes by providing a benchmark for impurity control strategies.

Basic Information

Product Name	Epirubicin Ep Impurity G
CAS No.	1046827-43-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4'-Epi-doxorubicin impurity G; Epirubicin Related Compound G; 4'-Epidoxorubicin EP Impurity G; (7S,9S)-7-[(2R,4S,5S,6S)-4-Amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione; Doxorubicin, 4'-epi-, impurity G (EP); Epirubicin Impurity G (EP)
EINECS	Contact for details

Quality Control

Our Epirubicin Ep Impurity G is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	Red to reddish-brown solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
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.