Description

Glimepiride-D5 is a stable isotope-labeled analog of the widely used sulfonylurea antidiabetic agent, Glimepiride, where five hydrogen atoms are replaced by deuterium. This compound is an essential internal standard for the precise and accurate quantification of Glimepiride in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and drug metabolism research to ensure data integrity and regulatory compliance.

Application

• Internal Standard for Bioanalysis: Serves as a critical reference compound in the quantitative LC-MS/MS analysis of Glimepiride in plasma, serum, and other biological samples.
• Pharmacokinetic and Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Bioequivalence Testing: Essential for validating analytical methods in studies comparing generic and brand-name formulations of Glimepiride.
• Drug Impurity Profiling: Used as a reference marker in method development for identifying and quantifying potential deuterated impurities or metabolites.
• Regulatory Submission Support: Provides the high-quality data traceability required for dossiers submitted to agencies like the FDA and EMA.
• Stable Isotope Labeling Research: Acts as a model compound in methodological research focusing on the application of deuterated standards.

Basic Information

Product Name	Glimepiride-D5
CAS No.	1028809-90-6
Molecular Formula	C24H29D5N3O5S
Molecular Weight	494.64 g/mol
Synonyms	1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea-d5; Deuterated Glimepiride; Glimepiride (phenyl-d5); Amaryl-d5; HOE 490-d5; 3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamide-d5 derivative; Stable Isotope-Labeled Glimepiride
EINECS	Contact for details

Quality Control

Every batch of Glimepiride-D5 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR (1H, 13C), Mass Spectrometry, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of unlabeled parent compound. Our quality commitment ensures the material meets the stringent requirements for use in GLP/GMP-compliant analytical laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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	≥ 98.0 atom % D
Chemical Purity	≥ 95.0% (by NMR)
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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