Description

[2H5]-Loteprednol Etabonate is a deuterated isotopologue of the potent corticosteroid loteprednol etabonate, specifically labeled with five deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in the development and validation of assays for ophthalmic and anti-inflammatory drugs.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity, non-interfering internal standard for the precise quantification of loteprednol etabonate in biological matrices (e.g., plasma, tears, tissue homogenates) using liquid chromatography-tandem mass spectrometry.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioanalytical Method Development & Validation: Used to establish robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Stable Isotope Dilution Analysis (SIDA): Facilitates highly accurate quantification by correcting for analyte loss during sample preparation and instrument variability.
• Metabolite Identification and Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex biological samples.
• Quality Control in Pharmaceutical Manufacturing: Can be employed in specialized QC protocols to monitor process-related impurities or degradation products in active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	[2H5]-Loteprednol Etabonate
CAS No.	2026643-11-6
Molecular Formula	C24H31D5O7
Molecular Weight	Approx. 467.56 g/mol
Synonyms	Loteprednol Etabonate-d5; Chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate-d5; 17β-[(Ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17α-carboxylic Acid Chloromethyl Ester-d5; Deuteronated Loteprednol Etabonate; Loteprednol-d5 Etabonate; Stable Isotope-Labeled Loteprednol Etabonate; Internal Standard for Loteprednol
EINECS	Contact for details

Quality Control

Our [2H5]-Loteprednol Etabonate is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm identity, isotopic enrichment (typically ≥98 atom % D), and chemical purity (typically ≥95%). A comprehensive Certificate of Analysis (COA) detailing all specifications and test results is provided with every shipment to support your regulatory and research documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive); the container must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity (NMR/MS)	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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