Description

Azithromycin Monohydrate is a broad-spectrum macrolide antibiotic derived from erythromycin, widely recognized for its potent activity against a variety of Gram-positive and Gram-negative pathogens. Its monohydrate form offers enhanced stability and is a critical active pharmaceutical ingredient (API) for the formulation of reliable and effective antibiotic treatments. This compound is essential for pharmaceutical manufacturers producing oral solid dosage forms, such as tablets and capsules, as well as sterile injectable solutions, to combat bacterial infections in both human and veterinary medicine.

Application

• Primary Active Pharmaceutical Ingredient (API) in the manufacture of oral antibiotic tablets and capsules.
• Key component in the formulation of sterile injectable antibiotic solutions for hospital and clinical use.
• Used in veterinary pharmaceuticals for the treatment of bacterial infections in livestock and companion animals.
• Intermediate in the synthesis of more complex antibiotic derivatives and prodrugs.
• Reference standard in analytical laboratories for quality control and pharmacological research.
• Raw material for the production of pediatric suspension formulations.

Basic Information

Product Name	Azithromycin Monohydrate
CAS No.	121470-24-4
Molecular Formula	C38H72N2O12 • H2O
Molecular Weight	749.00 g/mol (Monohydrate)
Synonyms	9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A Monohydrate; Azithromycin Hydrate; CP-62993; XZ-450; Zithromax (Trade Name); Azyter; Sumamed; Azithromycin Dihydrate (common misnomer); Z-Pak
EINECS	Contact for details

Quality Control

Our Azithromycin Monohydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopoeial standards such as USP and EP. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with your specified requirements.

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). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC, on anhydrous basis)	98.0% - 102.0%
Water Content (Karl Fischer)	2.0% - 5.0%
Related Substances (HPLC)	Total impurities: NMT 2.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Specific Rotation	-45° to -49° (c=1, in chloroform)
pH (in methanol)	9.0 - 11.0

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