Description

Fexofenadine-D10 is a stable isotope-labeled analog of the active pharmaceutical ingredient fexofenadine, specifically deuterated at ten positions. This high-purity reference standard is essential for ensuring accurate and reliable quantitative analysis in complex matrices. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for method development, validation, and pharmacokinetic studies. The compound serves as a critical internal standard in LC-MS/MS and GC-MS assays, providing superior data integrity for bioanalytical and metabolic research.

Application

• Used as an internal standard for the precise quantification of fexofenadine in biological samples (e.g., plasma, serum, urine) via mass spectrometry.
• Critical for method development and validation in bioanalytical laboratories to meet FDA and ICH regulatory guidelines.
• Enables accurate pharmacokinetic and metabolism studies in both preclinical and clinical research settings.
• Supports quality control and impurity profiling in the manufacturing of fexofenadine-based pharmaceutical products.
• Facilitates doping control analysis in sports medicine to detect and confirm the presence of the parent drug.
• Employed in environmental fate studies to trace and quantify pharmaceutical residues.

Basic Information

Product Name	Fexofenadine-D10
CAS No.	1215900-18-7
Molecular Formula	C32H29D10NO4
Molecular Weight	516.71 g/mol (for deuterated form)
Synonyms	Fexofenadine-d10; [2H10]-Fexofenadine; (±)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic Acid-d10; Allegra-d10; Telfast-d10; MDL 16455A-d10; Carboxyterfenadine-d10
EINECS	Contact for details

Quality Control

Our Fexofenadine-D10 is manufactured under strict quality systems to ensure the highest isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment (≥98 atom % D), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We adhere to relevant industry standards for reference materials. Certificates of Analysis (COA) are available upon request.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Isotopic Purity	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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