Description

Glimepiride-D4 is a deuterium-labeled analog of the widely used sulfonylurea antidiabetic agent, Glimepiride. This high-purity stable isotope-labeled compound is an essential reference standard and internal standard for quantitative bioanalytical research, ensuring accurate and reliable pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug development and regulatory compliance testing.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) for the quantification of Glimepiride in biological matrices.
• Critical component in pharmacokinetic (PK) and bioequivalence studies to determine drug absorption, distribution, metabolism, and excretion.
• Reference material for metabolite identification and profiling in drug metabolism and pharmacodynamics (DMPK) research.
• Calibration standard in the development and validation of analytical methods according to FDA, EMA, and ICH guidelines.
• Used in clinical research to monitor drug levels and ensure patient safety and efficacy during trials.
• Essential for doping control analysis in sports to accurately detect and quantify prohibited substances.
• Tool in forensic toxicology for the precise measurement of Glimepiride in complex samples.

Basic Information

Product Name	Glimepiride-D4
CAS No.	1131981-29-7
Molecular Formula	C24H30D4N4O5S
Molecular Weight	494.64 g/mol (for deuterated form)
Synonyms	1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea-d4; Deuterated Glimepiride; Glimepiride (methyl-d3, cyclohexyl-d); Amaryl-d4; HOE 490-d4; 3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamide-d4 derivative; Stable Isotope Labeled Glimepiride
EINECS	Contact for details

Quality Control

Our Glimepiride-D4 is manufactured under strict quality control protocols to ensure the highest isotopic purity and chemical integrity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm identity, chemical purity, and isotopic enrichment. Certificates of Analysis (COA) detailing lot-specific data are provided and traceable to relevant standards for research use.

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 must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere to maintain stability.

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 (Deuterium Enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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