Description

Erythromycin Estolate CAS NO 3521-62-8 is a macrolide antibiotic salt, specifically the lauryl sulfate salt of erythromycin propionate. This formulation is designed to enhance the stability and oral bioavailability of the active pharmaceutical ingredient. It is a critical intermediate and active ingredient used in the manufacture of finished dosage forms for treating a wide range of bacterial infections. This product is essential for pharmaceutical manufacturers, veterinary medicine producers, and research institutions developing antimicrobial therapies.

Application

• Human Pharmaceutical Formulations: Primary use in the production of oral solid dosage forms (tablets, capsules) and suspensions for treating respiratory tract, skin, and soft tissue infections.
• Veterinary Medicine: Used in the manufacture of medicated feeds, premixes, and injectables for livestock, poultry, and companion animals.
• Active Pharmaceutical Ingredient (API): Serves as the key raw material for compounding pharmacies and generic drug manufacturers.
• Clinical Research: Utilized as a reference standard and in preclinical studies for evaluating antibiotic efficacy and pharmacokinetics.
• Antibiotic Resistance Studies: Employed in microbiological laboratories for susceptibility testing and research on macrolide resistance mechanisms.

Basic Information

Product Name	Erythromycin Estolate
CAS No.	3521-62-8
Molecular Formula	C40H71NO14 · C12H26O4S
Molecular Weight	1056.40 g/mol
Synonyms	Erythromycin Propionate Lauryl Sulfate; Erythromycin Estolate; Ilosone; Eromycin; Erythrocin Estolate; Erythromycin Estolate USP; Erythromycin 2'-Propionate Dodecyl Sulfate Salt; Erythromycin Propionate Dodecyl Sulfate
EINECS	222-543-4

Quality Control

Our Erythromycin Estolate is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Our products undergo rigorous quality testing to ensure compliance with industry standards for identity, purity, potency, and specified impurities. Certificates of Analysis (COA) detailing batch-specific results are available upon request, providing full traceability and supporting regulatory submissions for GMP-compliant manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment away from direct light exposure to maintain stability and potency.

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)	95.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 4.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 2.0% Total impurities: ≤ 5.0%
Microbial Enumeration	Meets USP/EP criteria

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