Description

Tolbutamide-D9 is a deuterated analog of the first-generation sulfonylurea drug, Tolbutamide, specifically labeled with nine deuterium atoms. This stable isotope-labeled compound is an essential internal standard for the precise quantification of Tolbutamide in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is a critical tool for researchers and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors, ensuring accurate pharmacokinetic studies, drug metabolism research, and bioanalytical method development.

Application

• Internal Standard for Bioanalysis: Primary use as a stable isotope-labeled internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of Tolbutamide in plasma, serum, and other biological fluids.
• Pharmacokinetic and Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development and Validation: Serves as a critical reference material for developing, optimizing, and validating robust bioanalytical assays in compliance with regulatory guidelines (e.g., FDA, EMA).
• Drug Impurity Profiling: Used in analytical research to understand and characterize deuterated metabolites or related substances.
• Forensic and Clinical Toxicology: Supports accurate measurement in forensic analysis and therapeutic drug monitoring (TDM) programs.

Basic Information

Product Name	Tolbutamide-D9
CAS No.	1219794-57-6
Molecular Formula	C12H9D9N2O3S
Molecular Weight	279.38 g/mol
Synonyms	1-Butyl-3-(p-tolylsulfonyl)urea-D9; N-[(Butyl-d9)carbamoyl]-4-methylbenzenesulfonamide; Tolbutamide (phenyl-D5, butyl-D4); Deuterated Tolbutamide; Tolbutamide-d9; 4-Methyl-N-[(pentadeuteriopentyl)carbamoyl]benzenesulfonamide; Stable Isotope Labeled Tolbutamide
EINECS	Contact for details

Quality Control

Every batch of Tolbutamide-D9 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to ensure the product meets the high-purity requirements for use as an internal standard. A detailed Certificate of Analysis (COA) is supplied with each shipment, reporting key parameters such as isotopic purity, chemical purity, and residual solvent content. Our quality commitment supports compliance with the rigorous standards expected in pharmaceutical research and development.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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