Description

3’-n-Desmethyl-3’-n-Formyl Azithromycin is a key chemical intermediate and impurity reference standard in the synthesis and quality control of the macrolide antibiotic, Azithromycin. This compound is critical for pharmaceutical R&D and manufacturing, enabling precise analysis and ensuring the purity and efficacy of the final active pharmaceutical ingredient (API). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in antibiotic development and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthetic pathway for producing Azithromycin API.
• Analytical Reference Standard: Used as a certified impurity standard in HPLC and LC-MS methods for quality control of Azithromycin batches.
• Process Development & Validation: Essential for studying and optimizing synthesis routes, reaction mechanisms, and purification processes.
• Regulatory Compliance & Documentation: Supports the identification and quantification of related substances for regulatory filings (e.g., FDA, EMA).
• Research on Macrolide Antibiotics: Serves as a tool compound for structure-activity relationship (SAR) studies and metabolic pathway research.
• Method Development: Used to develop and validate stability-indicating assay methods for Azithromycin formulations.

Basic Information

Product Name	3’-n-Desmethyl-3’-n-Formyl Azithromycin
CAS No.	612069-28-0
Molecular Formula	C37H71N2O13
Molecular Weight	751.97 g/mol
Synonyms	Azithromycin 3'-N-Desmethyl-3'-N-Formyl Impurity; 3'-N-Desmethyl-3'-N-Formylazithromycin; 3'-N-Formyl-3'-N-Desmethylazithromycin; Azithromycin Impurity F (EP); Azithromycin Related Compound F; Azithromycin Desmethyl Formyl Impurity; 9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A, 3'-N-Desmethyl-3'-N-formyl-; (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,3S,4S,5S,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxy}-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one 3'-N-Formyl Derivative
EINECS	Contact for details

Quality Control

Our 3’-n-Desmethyl-3’-n-Formyl Azithromycin is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis and synthesis. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (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.