Description

Erythromycin Stearate is a macrolide antibiotic salt formed by combining erythromycin base with stearic acid, enhancing its stability and oral bioavailability. This compound is crucial for formulating effective and palatable oral antibiotic medications, particularly for patients with penicillin allergies. It is primarily required by pharmaceutical manufacturers for the production of tablets, capsules, and oral suspensions to treat a wide range of bacterial infections.

Application

• Pharmaceutical Formulations: Primary active ingredient in oral solid dosage forms like tablets and capsules.
• Pediatric & Geriatric Medicines: Key component in flavored oral suspensions and dry syrups for easier administration.
• Veterinary Pharmaceuticals: Used in medicated feeds and treatments for bacterial infections in livestock and companion animals.
• Respiratory Tract Infection Treatments: Formulated into medications targeting pneumonia, bronchitis, and other respiratory conditions.
• Skin and Soft Tissue Infection Drugs: Incorporated into systemic treatments for cellulitis and erysipelas.
• GMP-Compliant API Production: Serves as a critical starting material or intermediate in the synthesis of other advanced antibiotic formulations under Good Manufacturing Practices.

Basic Information

Product Name	Erythromycin Stearate
CAS No.	643-22-1
Molecular Formula	C37H67NO13 • C18H36O2
Molecular Weight	1018.41 g/mol
Synonyms	Erythromycin octadecanoate; Erythromycin stearate salt; Erythrocin Stearate; Abbott-24091; E-Mycin; Ilotycin; ERY; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,7,9,11,13-hexamethyl-1-oxacyclotetradecane-2,10-dione octadecanoate
EINECS	211-407-8

Quality Control

Our Erythromycin Stearate is manufactured and tested to meet stringent pharmacopeial standards, including USP, EP, and BP monographs. Every batch undergoes rigorous analytical testing for identity, potency, and purity. A comprehensive Certificate of Analysis (COA) detailing all test results is provided to ensure full traceability and compliance for our global B2B clients.

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 slightly yellow powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	95.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 4.0%
pH (in suspension)	6.0 - 8.5
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Microbial Enumeration	Meets EP/USP requirements

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