Description

Azithromycin Dihydrate is the dihydrate crystalline form of the broad-spectrum macrolide antibiotic azithromycin. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy, stability, and consistent performance of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers for the production of oral solid dosage forms, such as tablets and capsules, used to treat a wide range of bacterial infections.

Application

• Pharmaceutical API: Primary raw material in the manufacture of antibiotic medications.
• Tablet Formulation: Direct compression or granulation for oral tablet production.
• Capsule Filling: Used in powder or pellet form for hard gelatin or vegetarian capsules.
• Suspension Preparation: Micronized grade for pediatric and adult oral suspension formulations.
• Veterinary Pharmaceuticals: Active ingredient in antibiotics for animal health applications.
• Clinical Research: Reference standard or raw material for drug development and stability studies.

Basic Information

Product Name	Azithromycin Dihydrate
CAS No.	117772-70-0
Molecular Formula	C38H72N2O12 · 2H2O
Molecular Weight	785.0 g/mol (as dihydrate)
Synonyms	Azithromycin Dihydrate; 9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A Dihydrate; Azithromycin Hydrate; CP-62993 Dihydrate; Zithromax (brand name API); Azythromycin Dihydrate; Azitromax; Azitro; Azitrox
EINECS	Contact for details

Quality Control

Our Azithromycin Dihydrate is manufactured and tested under strict quality management systems. It is typically produced to meet or exceed relevant pharmacopeial standards such as USP, EP, and BP. Each batch undergoes comprehensive analytical testing including assay, identification, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to ensure full traceability and compliance.

Storage

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

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC, anhydrous basis)	98.0% - 102.0%
Water Content (KF)	4.0% - 6.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP
pH (in suspension)	9.0 - 11.0

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