Description

Azithromycin Impurity CAS NO 194809-66-0 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 is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Azithromycin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to verify that impurity levels are within ICH (Q3A, Q3B) and pharmacopeial (USP, EP) guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation and increase of this impurity over time in stability testing of Azithromycin formulations under various ICH storage conditions.
• Research & Development: Supports R&D efforts in understanding degradation pathways, synthesis process optimization, and developing purer manufacturing processes for Azithromycin.

Basic Information

Product Name	Azithromycin Impurity
CAS No.	194809-66-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azithromycin Related Compound; Azithromycin Degradant; Azithromycin Process Impurity; 9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A Impurity; (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 related substance
EINECS	Contact for details

Quality Control

Our Azithromycin Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and our processes support compliance with relevant ICH and cGMP guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% 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.