Description

Azelastine D4 is a deuterated isotopologue of the potent, selective histamine H1-receptor antagonist Azelastine, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity compound is essential for ensuring accuracy and reliability in mass spectrometry-based analyses, particularly in pharmacokinetic and metabolic studies. It is a critical material for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers requiring definitive quantification of Azelastine in complex biological matrices.

Application

• Internal Standard for LC-MS/MS: Primary use as a stable, isotopically labeled internal standard for the precise quantification of Azelastine in bioanalytical assays, minimizing matrix effects and improving data integrity.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Impurity Profiling: Used in method development and validation to identify and quantify potential deuterated impurities or related substances in drug substances and products.
• Forensic & Doping Control Analysis: Supports highly specific and confirmatory testing for Azelastine in forensic toxicology and anti-doping programs.
• Reference Material for GLP/GMP Compliance: Serves as a certified reference material in laboratories operating under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines.

Basic Information

Item	Detail
Product Name	Azelastine D4
CAS No.	1228258-93-2
Molecular Formula	C22H20D4ClN3O
Molecular Weight	~ 383.91 g/mol
Synonyms	4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one-d4; Deuterated Azelastine; Azelastine-(phenyl-d4); Azelastine-d4 Internal Standard; (RS)-Azelastine-d4; Afluon-d4; Allergodil-d4; Optivar-d4
EINECS	Contact for details

Quality Control

Every batch of Azelastine D4 is manufactured and controlled to meet the exacting standards required for analytical reference materials. Our rigorous quality testing includes comprehensive characterization to ensure isotopic purity, chemical purity, and structural identity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, isotopic enrichment (D4 content), and related substances by HPLC and LC-MS. We support compliance with ICH Q2(R1) guidelines for analytical method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry environment to prevent absorption of moisture.

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 (D4)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 95.0%
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.