Description

(±)-Sotalol-D7 Hcl (iso-Propyl-D7) CAS NO 1398065-65-0 is a high-purity, deuterium-labeled internal standard critical for advanced analytical applications. This compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses, particularly in pharmacokinetic and bioequivalence studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities for precise quantification of the parent drug, sotalol, in complex biological matrices.

Application

• Internal Standard for LC-MS/MS: Used as a deuterated internal standard for the accurate quantification of sotalol in biological fluids (plasma, serum, urine) during drug metabolism and pharmacokinetics (DMPK) studies.
• Pharmaceutical Research & Development: Supports method development and validation for bioanalytical assays in new drug formulation studies and generic drug development.
• Clinical Trial Analysis: Enables precise measurement of drug concentration in patient samples for therapeutic drug monitoring (TDM) and clinical pharmacology trials.
• Forensic and Toxicology Testing: Employed in confirmatory testing for sotalol in forensic investigations or cases of suspected overdose.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability-indicating assay methods for sotalol active pharmaceutical ingredient (API) and finished dosage forms.
• Metabolite Identification Studies: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex mass spectrometry data.

Basic Information

Item	Details
Product Name	(±)-Sotalol-D7 Hcl (iso-Propyl-D7)
CAS No.	1398065-65-0
Molecular Formula	C12H13D7ClN2O3S • HCl
Molecular Weight	335.31 g/mol (for monoisotopic)
Synonyms	N-[4-[1-Hydroxy-2-[(1-methylethyl-d7)amino]ethyl]phenyl]methanesulfonamide Hydrochloride; Sotalol-d7 Hydrochloride; Sotalol (iso-Propyl-d7) Hydrochloride; DL-Sotalol-d7 HCl; (±)-Sotalol-d7 Hydrochloride; 1-(4-((Methylsulfonyl)amino)phenyl)-2-(isopropyl-d7-amino)ethanol Hydrochloride; MJ 1999-d7
EINECS	Contact for details

Quality Control

Our (±)-Sotalol-D7 Hcl (iso-Propyl-D7) is manufactured under strict quality systems to ensure exceptional isotopic purity and chemical integrity. Each batch is characterized by advanced spectroscopic techniques including NMR (¹H, ¹³C) and High-Resolution Mass Spectrometry (HRMS) to confirm structure and isotopic enrichment. We provide comprehensive Certificates of Analysis (COA) detailing purity (by HPLC), chemical purity, isotopic purity (D-enrichment), and residual solvent content, supporting compliance with GLP/GMP guidelines for research use.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This compound is hygroscopic (moisture-sensitive). For long-term storage, consider desiccation. Keep container in a dry, well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spec)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98.0 atom % D
Chemical Purity (¹H NMR)	≥95.0%
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.