Description

Rebamipide-D4 is a deuterated analog of the gastroprotective agent Rebamipide, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative mass spectrometry, ensuring unparalleled accuracy and reliability in analytical measurements. It is a critical tool for pharmaceutical researchers and analytical laboratories engaged in drug metabolism and pharmacokinetic (DMPK) studies, bioanalytical method development, and quality control of Rebamipide-based formulations.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity, non-interfering internal standard for the precise quantification of Rebamipide in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism Studies (DMPK): Enables accurate tracking of the parent drug and its metabolites in absorption, distribution, metabolism, and excretion (ADME) research.
• Bioanalytical Method Development and Validation: Serves as a reference compound to establish robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Research: Facilitates reliable concentration determination in clinical and pre-clinical studies to understand drug efficacy and safety profiles.
• Pharmaceutical Quality Control: Used in the assay and impurity profiling of Rebamipide active pharmaceutical ingredients (APIs) and finished dosage forms.
• Stable Isotope Labeling Research: Acts as a model compound for studying isotopic effects or developing novel analytical techniques using deuterated markers.

Basic Information

Product Name	Rebamipide-D4
CAS No.	1219409-06-9
Molecular Formula	C19H15D4ClN2O4
Molecular Weight	370.83 g/mol (for deuterated form)
Synonyms	2-(4-Chlorobenzamido)-3-[2,3,5,6-tetradeutero-4(1H)-oxoquinolinyl]propanoic Acid; (±)-2-(4-Chlorobenzoylamino)-3-(2,3,5,6-tetradeutero-4-oxo-1,4-dihydro-2-quinolyl)propionic Acid; Rebamipide (tetradeutero, phenyl-2,3,5,6); OPC-12759 D4; Rebamipide-d4 (phenyl-D4); GASTROM D4; Mucosta D4
EINECS	Contact for details

Quality Control

Our Rebamipide-D4 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch undergoes comprehensive testing, including HPLC for chemical purity, NMR and MS for structural confirmation and isotopic enrichment, and residual solvent analysis. Certificates of Analysis (COA) detailing all specifications, including deuterium content, are provided 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 or CoA. The product is light-sensitive (store away from light). For long-term storage, consider desiccated conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0% (Chemical Purity)
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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