Description

Carboxy Gliclazide-D4 is a deuterium-labeled analog of the primary metabolite of the sulfonylurea drug Gliclazide. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical research and development laboratories, clinical testing facilities, and contract research organizations (CROs) focused on diabetes drug development and therapeutic drug monitoring.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative reference standard in Liquid Chromatography-Tandem Mass Spectrometry for the analysis of Gliclazide and its metabolites in biological matrices.
• Pharmacokinetic Studies: Enables precise measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Metabolite Profiling: Used in the identification and quantification of drug metabolites to understand metabolic pathways and potential active forms.
• Bioequivalence Testing: Supports high-precision analytical methods required for demonstrating bioequivalence in generic drug development.
• Therapeutic Drug Monitoring (TDM): Facilitates accurate assay development for monitoring Gliclazide plasma concentrations in diabetic patients.
• Drug Impurity and Degradation Studies: Serves as a reference marker in stability-indicating methods to track degradation products.

Basic Information

Product Name	Carboxy Gliclazide-D4
CAS No.	1346602-90-1
Molecular Formula	C15H17D4N3O3S
Molecular Weight	311.40 g/mol (for deuterated form)
Synonyms	1-(3-Azabicyclo[3.3.0]oct-3-yl)-3-(4-methylphenylsulfonyl)urea-d4 Carboxylic Acid Metabolite; Gliclazide Carboxylic Acid-d4; Gliclazide M1-d4; Gliclazide Metabolite (Carboxy)-d4; 3-[[(Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)amino]carbonyl]-4-methylbenzenesulfonamide-d4 Carboxylic Acid; 4-[[(Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)amino]carbonyl]sulfamoyl]-2-methylbenzoic acid-d4; Deuterated Carboxy Gliclazide; Gliclazide-D4 Carboxylic Acid
EINECS	Contact for details

Quality Control

Our Carboxy Gliclazide-D4 is manufactured under strict quality control protocols to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic purity (by MS), and residual solvents. We adhere to relevant industry standards for reference materials to support compliance in GLP and GMP environments.

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 kept in a dry environment. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
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.