Description

(S)-Viloxazine-D5 Hydrochloride CAS NO 1246816-39-6 is a deuterated isotopologue of the active pharmaceutical ingredient viloxazine, specifically labeled for use as an internal standard in quantitative bioanalytical methods. This high-purity reference material is critical for ensuring the accuracy and reliability of pharmacokinetic and metabolism studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and regulatory compliance.

Application

• Internal Standard for LC-MS/MS Analysis: Essential for the precise quantification of viloxazine and its metabolites in biological matrices such as plasma, serum, and urine.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Used to track drug absorption, distribution, metabolism, and excretion (ADME) with high specificity.
• Drug Metabolism Research: Facilitates the identification and measurement of metabolite profiles in pre-clinical and clinical studies.
• Bioequivalence and Bioanalytical Method Development: Serves as a critical component in validating robust analytical methods for regulatory submissions.
• Quality Control in Reference Material Production: Acts as a certified reference standard for calibrating assays and ensuring batch-to-batch consistency.

Basic Information

Product Name	(S)-Viloxazine-D5 Hydrochloride
CAS No.	1246816-39-6
Molecular Formula	C15H18D5NO3·HCl
Molecular Weight	~308.8 g/mol (for monoisotopic)
Synonyms	(S)-2-[(2-Ethoxyphenoxy)methyl]morpholine-D5 Hydrochloride; Viloxazine-D5 HCl; Deuterated Viloxazine Hydrochloride; (S)-Viloxazine (phenyl-D5) Hydrochloride; SPN-812-D5 (Hydrochloride); VLD5-HCl
EINECS	Contact for details

Quality Control

Every batch of (S)-Viloxazine-D5 Hydrochloride is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) detailing identity, purity (by HPLC), isotopic enrichment, and impurity profiles to meet the exacting standards of analytical and pharmaceutical research. Our quality commitment ensures compliance with the principles of GMP for Active Pharmaceutical Ingredients (APIs) and reference standards.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥98 atom % D
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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