Description

Azithromycin Impurity B is a specified impurity and degradation product of the broad-spectrum macrolide antibiotic, Azithromycin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily used by analytical laboratories and pharmaceutical manufacturers involved in method validation, stability studies, and ensuring the purity and safety of Azithromycin-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Azithromycin Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Stability and Forced Degradation Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control & Assurance (QC/QA): A critical tool for in-process testing and batch release to ensure impurity profiles are within specified limits per pharmacopeial standards (USP, EP).
• Regulatory Submissions: Supports the preparation of regulatory dossiers for FDA, EMA, and other global health authorities by providing necessary impurity characterization data.
• Research on Degradation Pathways: Facilitates chemical research to understand the degradation mechanisms of Azithromycin, aiding in the development of more stable formulations.

Basic Information

Product Name	Azithromycin Impurity B
CAS No.	307974-61-4
Molecular Formula	C38H72N2O12
Molecular Weight	749.00 g/mol
Synonyms	(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,4R,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 Related Compound B; Desosaminylazithromycin; 9a-Aza-9a-homoerythromycin A; Azithromycin EP Impurity B; Azithromycin USP Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Azithromycin Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including chromatographic purity and identification data. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to air.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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