Description

Loteprednol Etabonate Ethyl Ester (Prednisolone 20-Ethyl Ester) is a key pharmaceutical intermediate and a synthetic corticosteroid derivative. This compound is of significant commercial importance as a crucial precursor in the synthesis of Loteprednol Etabonate, a modern ophthalmic corticosteroid used for its potent anti-inflammatory effects with a favorable safety profile. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of ophthalmic and topical anti-inflammatory medications.

Application

• Primary Pharmaceutical Intermediate: The principal application is as a critical synthetic precursor in the multi-step manufacturing process of the active pharmaceutical ingredient (API) Loteprednol Etabonate.
• Ophthalmic Drug Synthesis: Used in the production of corticosteroid-based eye drops and suspensions for treating post-operative inflammation, allergic conjunctivitis, and other ocular inflammatory conditions.
• Topical Corticosteroid Development: Serves as a building block in research and development for novel topical anti-inflammatory and anti-pruritic formulations.
• Process Chemistry & Scale-Up: Employed in process optimization, route scouting, and pilot-scale synthesis within pharmaceutical R&D and manufacturing departments.
• Reference Standard: Can be utilized as a high-purity chemical reference standard (CRS) for analytical method development, validation, and quality control testing of the final API.
• Metabolite & Derivative Research: Acts as a starting material for the synthesis of related metabolites or novel derivatives in medicinal chemistry research programs.

Basic Information

Product Name	Loteprednol Etabonate Ethyl Ester (Prednisolone 20-Ethyl Ester)
CAS No.	182069-19-8
Molecular Formula	C₂₆H₃₄O₇
Molecular Weight	458.55 g/mol
Synonyms	Loteprednol Etabonate Impurity C; Chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate; 17α-Ethoxycarbonyloxy-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylic Acid Chloromethyl Ester; Prednisolone 20-Ethyl Ester; 11β,17α-Dihydroxy-3,20-dioxopregna-1,4-dien-21-oic Acid Ethyl Ester; Loteprednol Etabonate Related Compound C; LE Ethyl Ester; (11β,17α)-17-[(Ethoxycarbonyl)oxy]-11-hydroxy-3-oxopregna-1,4-diene-21-carboxylic Acid Chloromethyl Ester
EINECS	Contact for details

Quality Control

Our Loteprednol Etabonate Ethyl Ester is manufactured under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure high chemical purity and identity confirmation, suitable for use in pharmaceutical synthesis. Certificates of Analysis (COA) detailing batch-specific results are provided and can be tailored to meet specific customer requirements or compendial standards (e.g., USP reference standards).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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