Description

Azithromycin CAS NO 83905-01-5 is a broad-spectrum macrolide antibiotic belonging to the azalide subclass, widely recognized for its potent activity against a variety of Gram-positive and Gram-negative bacteria. Its primary value lies in its extended half-life and excellent tissue penetration, enabling effective short-course treatment regimens. This high-purity active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical industry formulating oral solid dosages, suspensions, and injectable products to combat respiratory, skin, and sexually transmitted infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antibiotic tablets, capsules, and dry syrups.
• Injectable Formulations: Used in the production of sterile solutions for intravenous administration in hospital settings.
• Veterinary Medicine: Incorporated into medicated feeds and treatments for bacterial infections in livestock and companion animals.
• Research & Development: Serves as a critical reference standard and building block in microbiological and pharmacological research.
• Bulk Drug Substance: Supplied to contract manufacturing organizations (CMOs) for large-scale production of finished dosage forms.

Basic Information

Product Name	Azithromycin
CAS No.	83905-01-5
Molecular Formula	C38H72N2O12
Molecular Weight	749.00 g/mol
Synonyms	Azithromycin; Azithromycin Dihydrate; 9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A; Zithromax; CP-62993; Azaerythromycin; Sumamed; Azitrocin; Azitromax; Azithromycin Monohydrate
EINECS	Contact for details

Quality Control

Our Azithromycin is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards including USP, EP, and JP. Every batch undergoes comprehensive analytical testing for identity, potency, and purity. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided to ensure full traceability and regulatory support for your projects.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	4.0% - 6.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%; Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Sulfated Ash	≤ 0.2%
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Complies with EP/USP

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