Description

Repaglinide M2-D5 is a deuterated analog of the Repaglinide metabolite M2, serving as a critical stable isotope-labeled internal standard for precise bioanalytical quantification. This high-purity reference material is essential for ensuring accuracy and reliability in pharmacokinetic and metabolic studies, particularly in the development and quality control of antidiabetic pharmaceuticals. It is primarily utilized by research institutions, pharmaceutical R&D laboratories, and CROs specializing in advanced mass spectrometry and analytical method development.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of Repaglinide and its metabolites in biological matrices.
• Critical component in pharmacokinetic (PK) and bioequivalence studies to ensure accurate measurement of drug concentration over time.
• Facilitates drug metabolism and disposition (DMPK) research, aiding in the understanding of Repaglinide's metabolic pathways.
• Supports method development and validation in analytical laboratories for regulatory compliance (e.g., FDA, EMA).
• Enables high-accuracy therapeutic drug monitoring (TDM) in clinical research settings.
• Used in the manufacturing and quality control of generic and innovative antidiabetic drug formulations.

Basic Information

Product Name	Repaglinide M2-D5
CAS No.	1363721-68-9
Molecular Formula	C24H27D5N2O4
Molecular Weight	Approx. 418.55 g/mol
Synonyms	Repaglinide-d5 Metabolite M2; 2-Ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]-D5-benzoic Acid; (S)-2-Ethoxy-4-(2-((3-methyl-1-(2-(piperidin-1-yl)phenyl)butyl)amino)-2-oxoethyl)benzoic-d5 Acid; Deuterated Repaglinide Acid Metabolite; AG-EE 388 ZW-d5; Stable Isotope-Labeled Repaglinide M2.
EINECS	Contact for details

Quality Control

Our Repaglinide M2-D5 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including NMR, HPLC, and MS. We adhere to ISO 9001 quality management principles, and our production processes are designed to meet the rigorous standards expected by pharmaceutical and research industries.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container must be sealed immediately after use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Chemical Purity	≥ 95%
Water Content (KF)	≤ 1.0%
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.