Description

Azelastine-13C,D3 n-Oxide (Mixture Of Diastereomers) is a stable isotope-labeled analog of a key metabolite of the antihistamine drug Azelastine. This compound is essential for high-precision quantitative analysis in pharmacokinetic and metabolism studies, providing superior accuracy and reliability. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in advanced drug development and bioanalytical method validation.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard for the accurate quantification of Azelastine and its metabolites in biological matrices (plasma, serum, urine) using liquid chromatography-tandem mass spectrometry.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in ADME (Absorption, Distribution, Metabolism, Excretion) studies to trace and quantify metabolic pathways and clearance rates.
• Bioanalytical Method Development and Validation: Enables the development of highly specific and sensitive analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Facilitates precise drug level monitoring in human and animal clinical trials to ensure safety and efficacy.
• Forensic and Anti-Doping Analysis: Applied in specialized testing for the detection and confirmation of pharmaceutical substances.
• Reference Standard for Impurity Profiling: Acts as a certified reference material for identifying and quantifying related substances and degradation products in drug substances and products.

Basic Information

Product Name	Azelastine-13C,D3 n-Oxide (Mixture Of Diastereomers)
CAS No.	1346602-76-3
Molecular Formula	C22H21D3 13C N3O2
Molecular Weight	~ 384.46 g/mol
Synonyms	4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)-1(2H)-phthalazinone-13C,D3 N-Oxide; Azelastine N-Oxide-13C,D3; Deuterated and 13C-Labeled Azelastine N-Oxide; Isotopically Labeled Azelastine Metabolite; (RS)-Azelastine-13C,D3 N-Oxide; Azelastine-d3-13C N-Oxide; Stable Isotope Labeled Azelastine N-Oxide
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Azelastine-13C,D3 n-Oxide is characterized using advanced analytical techniques to confirm identity, isotopic purity, and chemical purity. Certificates of Analysis (COA) are provided, detailing results for assay, isotopic enrichment, and related substances. We adhere to stringent quality management protocols suitable for pharmaceutical research applications.

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) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95%
Isotopic Purity (MS)	≥ 99 atom % 13C; ≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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