Description

Azithromycin n-Oxide is a key chemical intermediate and metabolite derived from the macrolide antibiotic azithromycin. This compound is of significant value in pharmaceutical research and development, particularly for studying drug metabolism, pharmacokinetics, and for the synthesis of novel derivatives. It is primarily utilized by research institutions, pharmaceutical manufacturers, and analytical laboratories engaged in antibiotic development, impurity profiling, and advanced chemical synthesis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of azithromycin-related impurities in drug substances and finished products.
• Metabolite Studies: Critical for in-vitro and in-vivo metabolism research to understand the biotransformation pathways of azithromycin.
• Process Impurity Profiling: Employed in quality control laboratories to monitor and control the formation of oxidative impurities during azithromycin API manufacturing.
• Chemical Synthesis Intermediate: Serves as a building block for the synthesis of new macrolide derivatives with potential modified biological activity.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC or LC-MS methods for azithromycin-based formulations.

Basic Information

Product Name	Azithromycin n-Oxide
CAS No.	90503-56-3
Molecular Formula	C38H72N2O13
Molecular Weight	764.99 g/mol
Synonyms	Azithromycin N-Oxide; 9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A N-Oxide; Azithromycin Impurity F (EP); Azithromycin N-Oxide Impurity; Azithromycin Related Compound F; 9a-Aza-9a-homoerythromycin A, 9-deoxo-9a-methyl-, N-oxide
EINECS	Contact for details

Quality Control

Our Azithromycin n-Oxide is produced and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets high-purity standards suitable for research and development. A detailed Certificate of Analysis (COA) specifying batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

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%
Water Content	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.