Description

Erythromycin Impurity CAS NO 40554-78-7 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Erythromycin-based antibiotics. This impurity is critical for ensuring the safety and efficacy of final drug products by enabling accurate identification, quantification, and monitoring during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the pharmaceutical and biotechnology industries focused on antibiotic production and compliance.

Application

• Primary use as a certified reference standard for analytical method development and validation (HPLC, LC-MS).
• Critical component in pharmaceutical impurity profiling and stability studies for Erythromycin API and formulations.
• Essential for regulatory compliance and submission to agencies like the FDA and EMA, supporting CMC documentation.
• Used in quality control laboratories for routine batch testing and release of Erythromycin products.
• Serves as a research tool in pharmacokinetic and metabolic studies of macrolide antibiotics.
• Supports pharmacopoeial testing to meet USP, EP, or other international monograph requirements.

Basic Information

Product Name	Erythromycin Impurity
CAS No.	40554-78-7
Molecular Formula	C37H67NO13
Molecular Weight	733.93 g/mol
Synonyms	Erythromycin, 8,9-Anhydro-6,9-hemiketal; 8,9-Anhydroerythromycin A 6,9-hemiketal; Erythromycin A enol ether; Erythromycin Impurity A; Erythromycin Anhydro; (8S,9R)-8,9-Anhydroerythromycin A 6,9-hemiketal; Erythralosamine
EINECS	Contact for details

Quality Control

Every batch of Erythromycin Impurity CAS NO 40554-78-7 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC and spectroscopic methods, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use in regulatory filings.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.