Description

Loteprednol is a synthetic corticosteroid specifically designed for topical ophthalmic use. Its primary value lies in its potent anti-inflammatory and immunosuppressive activity with a favorable safety profile, making it a critical active pharmaceutical ingredient (API) for treating ocular inflammation. This compound is essential for pharmaceutical manufacturers developing prescription eye drops and ointments to manage conditions such as post-operative inflammation, allergic conjunctivitis, and uveitis. Its targeted action helps minimize systemic side effects, a key concern in ophthalmic therapy.

Application

• Ophthalmic Anti-inflammatory Formulations: Primary use as the active ingredient in prescription eye drops (suspensions and solutions) for treating post-operative inflammation following cataract surgery.
• Allergic Conjunctivitis Treatment: Key component in medications designed to relieve the signs and symptoms of seasonal and perennial allergic conjunctivitis.
• Uveitis and Ocular Inflammatory Disorders: Used in therapeutic formulations to manage anterior uveitis and other non-infectious inflammatory conditions of the eye.
• Vernal Keratoconjunctivitis (VKC) Therapy: Incorporated into specialized ophthalmic preparations for managing this severe, chronic allergic eye disease.
• Pharmaceutical R&D: Serves as a reference standard and a key intermediate in research for developing novel corticosteroid derivatives with improved ocular bioavailability.
• Generic Drug Manufacturing: Critical API for producing generic versions of branded loteprednol etabonate ophthalmic medications, ensuring cost-effective treatment options.

Basic Information

Product Name	Loteprednol
CAS No.	129260-79-3
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; P-5604; AL-6215; LE; Lotemax® (Brand Name); Alrex® (Brand Name)
EINECS	Contact for details

Quality Control

Our Loteprednol is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines for active pharmaceutical ingredients (APIs). Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, to ensure high purity and consistency. Certificates of Analysis (COA) detailing all specified parameters are provided with every shipment to support your regulatory and manufacturing requirements.

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 container should be kept tightly sealed when not in 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)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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