Description

Fexofenadine-D6 Methyl Ester is a high-purity, stable isotope-labeled internal standard critical for advanced analytical quantification. This deuterated compound is essential for ensuring the accuracy, precision, and reliability of mass spectrometry-based analyses by correcting for instrument variability and sample preparation losses. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in method development, pharmacokinetic studies, and bioequivalence assessments for the antihistamine fexofenadine.

Application

• Quantitative Bioanalysis: Serves as an internal standard in LC-MS/MS and GC-MS methods for the precise quantification of fexofenadine in biological matrices such as plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and pre-clinical research.
• Drug Metabolism and Disposition Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of fexofenadine.
• Quality Control & Impurity Profiling: Supports analytical method validation and impurity characterization in active pharmaceutical ingredient (API) and finished product manufacturing.
• Forensic and Doping Control Analysis: Provides a reliable reference for the confirmatory analysis of fexofenadine in forensic toxicology and anti-doping programs.

Basic Information

Product Name	Fexofenadine-D6 Methyl Ester
CAS No.	1286458-00-1
Molecular Formula	C32H35D6NO4
Molecular Weight	~ 513.7 g/mol
Synonyms	Fexofenadine-d6 Methyl Ester; (±)-[4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid methyl ester-d6; Terfenadine Carboxylate Metabolite Methyl Ester-d6; Carboxyterfenadine Methyl Ester-d6; MDL 16455A-d6; HMR 38148-d6; Allegra Internal Standard-d6; Telfast-d6 Methyl Ester
EINECS	Contact for details

Quality Control

Every batch of Fexofenadine-D6 Methyl Ester is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data from NMR (¹H, ¹³C), Mass Spectrometry, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity (typically ≥98% by HPLC), isotopic enrichment (≥98 atom % D), and absence of unlabeled analog.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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