Description

Fexofenadine-D10 Hydrochloride is a stable isotope-labeled analog of the active pharmaceutical ingredient fexofenadine, where ten hydrogen atoms are replaced by deuterium. This high-purity compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolism studies. It is a critical material for pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the development and quality control of antihistamine medications.

Application

• Internal Standard for LC-MS/MS: Primary application as a deuterated internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the precise quantification of fexofenadine in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK): Used in absorption, distribution, metabolism, and excretion (ADME) studies to track and differentiate the parent drug from its metabolites.
• Bioequivalence and Clinical Trials: Critical for ensuring data integrity in bioanalytical assays supporting clinical trials and bioequivalence studies for generic fexofenadine formulations.
• Pharmaceutical Quality Control: Employed in advanced analytical methods for impurity profiling and assay validation of fexofenadine hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Forensic and Anti-Doping Analysis: Supports accurate detection and quantification of fexofenadine in forensic toxicology and sports anti-doping control programs.

Basic Information

Product Name	Fexofenadine-D10 Hydrochloride
CAS No.	1215821-44-5
Molecular Formula	C32H29D10ClNO4
Molecular Weight	~ 538.13 g/mol (deuterated form)
Synonyms	Fexofenadine-d10 HCl; [2H10]-Fexofenadine Hydrochloride; (±)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid-d10 hydrochloride; Allegra-d10 Hydrochloride; Telfast-d10 Hydrochloride; 2-[4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2-methylpropanoic acid-d10 hydrochloride; MDL 16455-d10 Hydrochloride
EINECS	Contact for details

Quality Control

Our Fexofenadine-D10 Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR (1H, 13C) and Mass Spectrometry for structural confirmation and deuterium incorporation verification, and HPLC for chemical and isotopic purity assessment. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified standards for use in regulated bioanalysis.

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) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (Mass Spec)	Conforms to structure
Deuterium Enrichment (NMR)	≥ 98 atom % D
Purity (HPLC)	≥ 98.0%
Chemical Purity (HPLC)	≥ 99.0%
Isotopic Purity	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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