Description

Repaglinide-Ethyl-D5 is a deuterated analog of the anti-diabetic drug Repaglinide, specifically labeled on the ethyl group. This stable isotope-labeled compound is essential for precise and reliable quantitative analysis in pharmacokinetic and metabolic studies. It serves as a critical internal standard in LC-MS/MS bioanalytical methods, ensuring accurate measurement of Repaglinide in biological matrices. Pharmaceutical research and development laboratories, as well as contract research organizations (CROs), require this high-purity reference material for method validation and regulatory compliance.

Application

• Primary use as an internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the bioanalysis of Repaglinide.
• Critical component in pharmacokinetic (PK) studies to determine drug absorption, distribution, metabolism, and excretion (ADME).
• Enables accurate quantification in clinical trial sample analysis, supporting drug development and regulatory submissions (e.g., to FDA, EMA).
• Used in metabolite identification and profiling research to understand drug metabolism pathways.
• Supports forensic and anti-doping analysis where precise measurement of drug concentrations is required.
• Essential for method development and validation in analytical laboratories to ensure accuracy, precision, and reproducibility.
• Applied in drug-drug interaction studies to monitor changes in Repaglinide plasma levels.

Basic Information

Product Name	Repaglinide-Ethyl-D5
CAS No.	1217709-85-7
Molecular Formula	C27H31D5N2O4
Molecular Weight	457.62 g/mol (approximate)
Synonyms	Repaglinide-d5 (ethyl-D5); 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)butylamino)-2-oxoethyl]-D5-benzoic Acid; Repaglinide Internal Standard D5; Repaglinide-d5 Ethyl Labeled; Deuterated Repaglinide (ethyl-D5); AG-EE 623 ZW-d5; NovoNorm-d5 (ethyl labeled)
EINECS	Contact for details

Quality Control

Our Repaglinide-Ethyl-D5 is manufactured under controlled conditions to ensure the highest isotopic and chemical purity, meeting the stringent requirements for analytical reference standards. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and related substances. We adhere to relevant quality guidelines to support your GLP and GMP-compliant research. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere in a sealed container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-content)	≥98 atom % D
Chemical Purity (by HPLC)	≥95.0%
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.