Description

Astemizole-D3 is a deuterium-labeled analog of the antihistamine astemizole, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity, isotopically labeled compound is essential for ensuring accuracy and reliability in mass spectrometry-based analyses, particularly in pharmacokinetic and metabolic studies. It is a critical tool for researchers and quality control laboratories in the pharmaceutical, contract research organization (CRO), and forensic toxicology sectors who require precise quantification of astemizole and its metabolites.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, non-interfering internal standard for the precise quantification of astemizole in complex biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic & Bioavailability Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Metabolite Identification & Profiling: Used in conjunction with parent compound analysis to identify and quantify metabolic pathways and products.
• Forensic & Clinical Toxicology: Supports the accurate determination of astemizole concentrations in cases of overdose or adverse drug reaction investigations.
• Pharmaceutical Quality Control & Method Development: Critical for developing and validating robust analytical methods for drug substance and product testing.
• Regulatory Compliance & DMPK Studies: Facilitates data generation that meets stringent regulatory requirements for drug metabolism and pharmacokinetics (DMPK) submissions.

Basic Information

Product Name	Astemizole-D3
CAS No.	1189961-39-4
Molecular Formula	C28H28D3FN4O
Molecular Weight	462.58 g/mol
Synonyms	1-[(4-Fluorophenyl)methyl]-N-[1-[2-(4-methoxyphenyl)ethyl]-4-piperidinyl]-1H-benzimidazol-2-amine-d3; Deuterated Astemizole; Astemizole Internal Standard; Astemizole-d3; [2H3]-Astemizole; (±)-Astemizole-d3; Astemizole (phenyl-d3)
EINECS	Contact for details

Quality Control

Our Astemizole-D3 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including NMR, HPLC, and LC-MS. We guarantee batch-to-batch consistency and compliance with the specifications agreed upon for your research or quality control protocols.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature before opening to minimize moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium incorporation)	≥ 99.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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