Description

(R)-Viloxazine-D5 Hydrochloride is a deuterated isotopologue of the chiral active pharmaceutical ingredient viloxazine, specifically labeled with five deuterium atoms. This high-purity reference standard is critical for ensuring accurate quantification and method validation in analytical research and development. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in pharmacokinetic, metabolic, and bioanalytical studies of viloxazine and related compounds.

Application

• Internal Standard for Bioanalysis: Serves as a stable, non-interfering internal standard in LC-MS/MS and GC-MS methods for the precise quantification of viloxazine in biological matrices like plasma, serum, and urine.
• Metabolite Tracing & Pharmacokinetics (PK): Enables detailed studies of drug absorption, distribution, metabolism, and excretion (ADME) using deuterium labeling to track the parent compound.
• Method Development & Validation: Essential for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Drug Impurity Profiling: Used as a reference marker to identify and quantify potential deuterated impurities or related substances in drug substances and products.
• Clinical Research Support: Provides a reliable standard for clinical trial sample analysis, ensuring data integrity for regulatory submissions.
• Stable Isotope Dilution Assays: Fundamental for high-accuracy assays where the deuterated analog compensates for sample preparation and ionization variability in mass spectrometry.

Basic Information

Product Name	(R)-Viloxazine-D5 Hydrochloride
CAS No.	1246815-04-2
Molecular Formula	C15H18D5NO2·HCl
Molecular Weight	~288.83 g/mol
Synonyms	2-[(2R)-2-[(1,1,2,2,2-Pentadeuterioethyl)amino]propyl]-5-methoxyphenol hydrochloride; Viloxazine-d5 (R-enantiomer) hydrochloride; (R)-2-[(α-Methylphenethyl)amino]-5-methoxy-2',2',2',1',1'-d5-phenethanol hydrochloride; Deuterated Viloxazine Hydrochloride; (R)-Viloxazine (pentadeuterio) Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of (R)-Viloxazine-D5 Hydrochloride is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR (1H, 13C), mass spectrometry, and chiral HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of significant impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (Deuterium Enrichment)	≥98 atom % D
Chiral Purity (Chiral HPLC)	≥99.0% (R-enantiomer)
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.