Description

Azithromycin Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the widely used macrolide antibiotic, Azithromycin. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and impurity profiling. Precise identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards and regulatory requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Azithromycin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Crucial for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Used to monitor the formation of degradation products in Azithromycin formulations under various stress conditions (e.g., heat, light, humidity).
• Pharmacopeial Testing: Aids in compliance testing against monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopeias.
• Research & Development: Employed in R&D to study the degradation pathways and chemical stability of Azithromycin, supporting the development of more robust formulations.

Basic Information

Product Name	Azithromycin Impurity 11
CAS No.	217500-34-0
Molecular Formula	C38H72N2O12
Molecular Weight	749.00 g/mol
Synonyms	Azithromycin Related Compound H; Azithromycin EP Impurity H; Azithromycin USP Impurity H; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-{[(2R,4S,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one; Azithromycin Impurity H
EINECS	Contact for details

Quality Control

Every batch of Azithromycin Impurity 11 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, UHPLC, and Mass Spectrometry (MS) to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

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 Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual 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.