Description

Erythromycin Impurity E(Ep) is a specified impurity of the macrolide antibiotic Erythromycin, identified by the CAS registry number 857839-61-3. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Erythromycin and its related drug substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Erythromycin Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Erythromycin formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes for Erythromycin by identifying and tracking this specific impurity.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability test component and for routine batch release testing to ensure impurity levels are within specified limits.

Basic Information

Product Name	Erythromycin Impurity E(Ep)
CAS No.	857839-61-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erythromycin E(Ep) Impurity; Erythromycin EP Impurity E; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione; Erythromycin related compound E (Epimer); Impurity E of Erythromycin (Epimer).
EINECS	Contact for details

Quality Control

Our Erythromycin Impurity E(Ep) is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity determination and spectroscopic methods for structural confirmation, to ensure identity, purity, and consistency. Certificates of Analysis (COA) containing detailed batch-specific results are provided and traceable to primary standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.