Description

Rac trans-Hydroxy Glimepiride-D5 is a deuterated isotopologue of a key hydroxy metabolite of the sulfonylurea drug glimepiride. This stable-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 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/MS) for the precise quantification of glimepiride and its metabolites in biological matrices.
• Critical component in pharmacokinetic (PK) and bioequivalence studies to monitor drug absorption, distribution, metabolism, and excretion.
• Supporting drug metabolism and disposition (DMPK) research to elucidate metabolic pathways and identify major circulating metabolites.
• Enhancing data integrity in clinical trial sample analysis for anti-diabetic drug development programs.
• Quality control applications in reference material and certified standard production for analytical laboratories.

Basic Information

Product Name	Rac trans-Hydroxy Glimepiride-D5
CAS No.	600177-94-4
Molecular Formula	C24H29D5N3O6S
Molecular Weight	~508.6 g/mol
Synonyms	trans-4-[2-[[3-Ethyl-4-methyl-2-oxo-3-(pentadeuterophenylsulfonyl)-1-pyrrolidinyl]carbonyl]amino]ethyl]benzenesulfonamide; Glimepiride Hydroxy Metabolite D5; Deuterated Glimepiride Metabolite; 3-[[trans-4-(Aminosulfonyl)phenyl]methyl]-5-methyl-4-[(pentadeuterophenyl)sulfonyl]-2-oxo-3-pyrrolidinecarboxamide; Rac-trans-Hydroxyglimepiride-d5; Stable Labeled Internal Standard for Glimepiride
EINECS	Contact for details

Quality Control

Every batch of Rac trans-Hydroxy Glimepiride-D5 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, confirmed by advanced spectroscopic and chromatographic techniques including NMR, HPLC, and LC-MS. A comprehensive Certificate of Analysis (COA) detailing purity, isotopic enrichment, and impurity profile is provided with each shipment to support your regulatory submissions and ensure traceability.

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 solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity	≥ 95%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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