Description

Erythromycin Aspartate is a water-soluble salt form of the macrolide antibiotic erythromycin, created by combining it with aspartic acid. This formulation enhances the stability and bioavailability of the active pharmaceutical ingredient, making it a critical component in advanced pharmaceutical manufacturing. It is primarily utilized by the pharmaceutical industry for the production of injectable and oral dosage forms requiring improved solubility and controlled release profiles.

Application

• Pharmaceutical Active Ingredient (API): Core component in the formulation of various antibiotic medications.
• Injectable Solutions: Used in sterile preparations for parenteral administration where high purity and solubility are paramount.
• Oral Suspensions and Tablets: Enhances the stability and efficacy of solid and liquid oral dosage forms.
• Veterinary Pharmaceuticals: Employed in antibiotic treatments for bacterial infections in animals.
• Research & Development: Serves as a standard or intermediate in pharmaceutical R&D for new drug delivery systems.
• Controlled-Release Formulations: Integral in developing sustained-release drug products to maintain therapeutic levels.

Basic Information

Product Name	Erythromycin Aspartate
CAS No.	30010-41-4
Molecular Formula	C40H73NO16 • C4H7NO4
Molecular Weight	938.04 g/mol (Erythromycin base: 733.93 g/mol)
Synonyms	Erythromycin L-Aspartate; Erythromycin Aspartate Salt; Erythromycin hydrogen L-aspartate; Erythromycin aspartate; L-Aspartic acid, compd. with erythromycin (1:1); Erythromycin monoaspartate; Ilotycin Aspartate
EINECS	250-001-8

Quality Control

Our Erythromycin Aspartate is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) documenting all test results is provided with each shipment.

Storage

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

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	95.0% - 102.0% (on anhydrous basis)
Water (Karl Fischer)	≤ 6.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Specific Rotation	-71° to -78° (c=1 in water)
pH (1% solution)	6.5 - 7.5

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