Description

Erythromycin Ep Impurity L is a high-purity chemical reference standard, specifically identified as an impurity of the macrolide antibiotic Erythromycin. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily used by research institutions, quality assurance laboratories, and API producers involved in the synthesis and purification of Erythromycin to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Erythromycin Ep Impurity L in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing to monitor impurity levels and ensure adherence to pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Erythromycin-based formulations.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Erythromycin Ep Impurity L
CAS No.	127955-44-6
Molecular Formula	C37H67NO13
Molecular Weight	733.93 g/mol
Synonyms	Erythromycin E; Erythromycin Epi-Impurity L; (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 Impurity E; Erythromycin Related Compound L
EINECS	Contact for details

Quality Control

Our Erythromycin Ep Impurity L is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide full traceability and Certificates of Analysis (COA) that detail batch-specific results, ensuring compliance with relevant pharmacopeial and ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
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%
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.