Description

Azithromycin Impurity 10 is a characterized impurity associated with the synthesis and stability of the broad-spectrum macrolide antibiotic, Azithromycin. This compound is essential for pharmaceutical research and development, serving as a critical reference standard for quality control and regulatory compliance. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure the purity, safety, and efficacy of Azithromycin drug substances and finished 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 dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical manufacturing to ensure compliance with pharmacopeial monographs (USP, EP, BP, JP).
• Stability Studies: Employed to track the formation of degradation products in Azithromycin formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Azithromycin, supporting formulation improvement and shelf-life extension.

Basic Information

Product Name	Azithromycin Impurity 10
CAS No.	620169-49-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azithromycin Related Compound; Azithromycin EP Impurity; Azithromycin USP Impurity; Azithromycin Degradant; Desosaminylazithromycin; (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
EINECS	Contact for details

Quality Control

Our Azithromycin Impurity 10 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and MS. The product is suitable for use as a reference standard in compliance with ICH Q3A/B guidelines and major pharmacopeias (USP, EP).

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.