Description

N',N'-Di(Desmethyl) Azithromycin is a key pharmaceutical intermediate and reference standard derived from the macrolide antibiotic azithromycin. This compound is of significant importance for research, development, and quality control processes in the pharmaceutical industry. It is primarily utilized by manufacturers and R&D laboratories involved in the synthesis, impurity profiling, and analytical validation of azithromycin-based active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC and other chromatographic methods in the quality control of azithromycin API and finished drug products.
• Process Development & Research: Serves as a critical intermediate in the synthetic pathway for developing novel macrolide derivatives and studying structure-activity relationships (SAR).
• Metabolite Studies: Employed in pharmacokinetic and metabolic research to understand the degradation pathways and biotransformation of azithromycin.
• Analytical Method Development: Essential for developing, validating, and calibrating sensitive analytical methods to ensure product purity and regulatory compliance.
• GMP Manufacturing: Used under controlled conditions for the production of high-purity azithromycin, ensuring batch-to-batch consistency.

Basic Information

Product Name	N',N'-Di(Desmethyl) Azithromycin
CAS No.	612069-27-9
Molecular Formula	C37H71N2O12
Molecular Weight	735.98 g/mol
Synonyms	2'-Deoxo-2'-(N,N-didesmethylamino)azithromycin; Azithromycin N',N'-Didesmethyl Impurity; Azithromycin Impurity F (EP); Azithromycin Related Compound F; 9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A N',N'-didesmethyl; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(Didesmethylamino)-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
EINECS	Contact for details

Quality Control

Our N',N'-Di(Desmethyl) Azithromycin is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are available upon request 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 a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
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.