Description

Gliclazide-D4 is a deuterated analog of the widely used sulfonylurea drug, Gliclazide, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is an essential reference standard and internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic 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 for type 2 diabetes medications.

Application

• Bioanalytical Reference Standard: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Gliclazide in biological matrices like plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in mass spectrometry-based studies to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of Gliclazide without isotopic interference.
• Clinical Research: Enables accurate therapeutic drug monitoring (TDM) and bioavailability/bioequivalence studies in clinical trials for anti-diabetic formulations.
• Pharmaceutical Quality Control: Acts as a certified reference material (CRM) for method development and validation in pharmaceutical quality assurance laboratories.
• Stable Isotope Labeling Studies: Facilitates research into metabolic pathways and the differentiation between endogenous and exogenous compounds in complex biological systems.

Basic Information

Item	Details
Product Name	Gliclazide-D4
CAS No.	1185039-30-8
Molecular Formula	C15H17D4N3O3S
Molecular Weight	328.40 g/mol (deuterated form)
Synonyms	1-(3-Azabicyclo[3.3.0]oct-3-yl)-3-(4-methylphenylsulfonyl)urea-d4; Gliclazide (methyl-d4); Gliclazide-d4; Deuterated Gliclazide; Gliclazide Internal Standard; Gliclazide Stable Isotope; N-[(Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)amino]carbonyl]-4-methylbenzenesulfonamide-d4
EINECS	Contact for details

Quality Control

Our Gliclazide-D4 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment (D%), chemical purity (by HPLC), and identification. We adhere to relevant guidelines for reference standards to ensure reliable and reproducible performance in your critical LC-MS/MS assays.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. The product is hygroscopic (moisture-sensitive) and should be kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D%)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 98.0%
Residual Solvents (GC)	Complies with ICH guidelines

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