Description

Ebastine-D5 is a deuterated isotopologue of the antihistamine drug ebastine, specifically labeled with five deuterium atoms. This compound is a critical internal standard used in quantitative analytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical research and development, clinical laboratories, and regulatory compliance testing within the life sciences sector.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard in LC-MS/MS and GC-MS methods for the precise quantification of ebastine and its metabolites in biological matrices like plasma, serum, and urine.
• Pharmacokinetic Studies: Enables accurate determination of drug absorption, distribution, metabolism, and excretion (ADME) profiles during preclinical and clinical trials.
• Metabolite Profiling: Aids in the identification and quantification of drug metabolites, facilitating a deeper understanding of metabolic pathways.
• Method Development & Validation: Critical for developing robust, selective, and sensitive analytical methods that meet regulatory standards (e.g., FDA, EMA).
• Doping Control & Forensic Analysis: Used in specialized testing to detect and confirm the presence of pharmaceutical agents.
• Quality Control in Manufacturing: Can be employed in analytical procedures to monitor the quality and consistency of active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	Ebastine-D5
CAS No.	338393-24-1
Molecular Formula	C32H34D5NO2
Molecular Weight	474.68 g/mol (approx.)
Synonyms	1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-(diphenylmethoxy)-1-piperidinyl]-1-butanone-d5; Ebastine (phenyl-d5); 4'-tert-Butyl-4-[4-(diphenylmethoxy)piperidino]butyrophenone-d5; (±)-Ebastine-d5; RS-5601-d5; LAS-W-090-d5; Ebastel-d5; Ebastel (phenyl-d5)
EINECS	Contact for details

Quality Control

Our Ebastine-D5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including NMR and mass spectrometry, to confirm isotopic purity, chemical purity, and structural identity. We provide comprehensive Certificates of Analysis (COA) detailing specifications for isotopic enrichment, chemical purity, and residual solvents, supporting compliance with GMP and ISO guidelines for reference standards.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines

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