Description

Loteprednol Etabonate is a synthetic corticosteroid specifically engineered for its potent anti-inflammatory activity with a favorable safety profile. This compound is of critical importance in the pharmaceutical industry for the development of topical ophthalmic solutions to treat post-operative inflammation and other ocular conditions. It is primarily required by pharmaceutical manufacturers and R&D facilities focused on advanced ophthalmic and dermatological therapeutics. Our supply of Loteprednol Etabonate CAS NO 82034-46-6 ensures high purity and reliable consistency for formulation development and commercial production.

Application

• Primary Active Pharmaceutical Ingredient (API) in prescription ophthalmic suspensions and ointments for treating inflammation and pain following ocular surgery.
• Key component in anti-allergic eye drops for managing seasonal allergic conjunctivitis and other ocular allergic reactions.
• Research and Development of novel topical corticosteroid formulations with reduced systemic side effects.
• Dermatological Preparations for the development of creams and lotions targeting inflammatory skin conditions.
• Reference Standard for quality control and analytical testing in pharmaceutical laboratories.
• Process Development for scale-up and optimization of synthetic pathways in API manufacturing.

Basic Information

Product Name	Loteprednol Etabonate
CAS No.	82034-46-6
Molecular Formula	C₂₄H₃₁ClO₇
Molecular Weight	466.95 g/mol
Synonyms	Loteprednol Etabonate; Chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate; (11β,17α)-17-[(Ethoxycarbonyl)oxy]-11-hydroxy-3-oxopregna-1,4-diene-21-carboxylic Acid Chloromethyl Ester; Loteprednol; LE; AL-6216; Lotemax® (brand name active ingredient); Zylet® (brand name active ingredient)
EINECS	Contact for details

Quality Control

Our Loteprednol Etabonate is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols are designed to ensure identity, purity, strength, and composition, aligning with current industry best practices for Active Pharmaceutical Ingredients (APIs). Certificates of Analysis (COA) documenting comprehensive testing results, including assay, related substances, and residual solvents, are provided with each batch to support your regulatory and formulation needs.

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 must be kept in a dry environment to prevent degradation. The original container should be kept tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details
Melting Point	Contact for details

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