Description

8-[2-(2,3,4,5,6-Pentadeuteriophenyl)Ethyl]-1-Oxa-3,8-Diazaspiro[4.5]Decan-2-One:Hydrochloride is a high-purity, deuterium-labeled chemical reference standard essential for advanced analytical research. This compound is critical for ensuring accuracy and reliability in quantitative mass spectrometry, where it serves as an internal standard to correct for instrument variability and matrix effects. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and forensic analysis.

Application

• Internal Standard for LC-MS/MS: Used as a stable isotope-labeled internal standard in liquid chromatography-tandem mass spectrometry for the precise quantification of its non-deuterated counterpart or related analogs in complex biological matrices.
• Drug Metabolism Studies (DMPK): Facilitates accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Enables the creation of robust, sensitive, and specific analytical methods compliant with FDA and ICH guidelines.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling: Provides essential data for modeling drug concentration-time profiles and effect relationships.
• Forensic and Clinical Toxicology: Supports the accurate identification and quantification of specific substances or their metabolites in forensic investigations and clinical screenings.
• Impurity Profiling and Degradation Studies: Aids in the identification and quantification of process-related impurities or degradation products during pharmaceutical development.

Basic Information

Product Name	8-[2-(2,3,4,5,6-Pentadeuteriophenyl)Ethyl]-1-Oxa-3,8-Diazaspiro[4.5]Decan-2-One:Hydrochloride
CAS No.	1246815-28-0
Molecular Formula	C17H20D5ClN2O2
Molecular Weight	339.88 g/mol (for monoisotopic mass)
Synonyms	8-[2-(2,3,4,5,6-Pentadeuteriophenyl)ethyl]-1-oxa-3,8-diazaspiro[4.5]decan-2-one hydrochloride; 1-Oxa-3,8-diazaspiro[4.5]decan-2-one, 8-[2-(2,3,4,5,6-pentadeuteriophenyl)ethyl]-, hydrochloride; Deuterated Spiro Compound Hydrochloride; (D5)-8-(2-Phenylethyl)-1-oxa-3,8-diazaspiro[4.5]decan-2-one hydrochloride; Pentadeutero Analog Hydrochloride Salt; Internal Standard for Spirocyclic Amine Analysis.
EINECS	Contact for details

Quality Control

Every batch of this deuterated standard is produced and analyzed under strict quality control protocols to ensure the highest isotopic purity and chemical integrity. Our comprehensive testing includes advanced spectroscopic and chromatographic methods to confirm identity, isotopic enrichment, and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data including assay, isotopic purity, and residual solvent content, supporting compliance with ICH Q3 and GMP guidelines for 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (LC-MS)	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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