Description

Racecadotril-D5 is a deuterated internal standard specifically designed for the precise quantification of Racecadotril in analytical research and development. This high-purity compound is essential for ensuring accuracy and reliability in mass spectrometry-based assays, such as LC-MS/MS, by correcting for variations in sample preparation and instrument response. It is a critical tool for pharmaceutical researchers, analytical chemists, and quality control laboratories involved in pharmacokinetic studies, bioequivalence testing, and impurity profiling of the antidiarrheal drug Racecadotril.

Application

• Primary use as an internal standard for the quantitative analysis of Racecadotril via Liquid Chromatography-Mass Spectrometry (LC-MS/MS).
• Method development and validation for bioanalytical assays in pharmacokinetic and pharmacodynamic studies.
• High-accuracy quantification of Racecadotril in complex biological matrices like plasma, serum, and urine.
• Quality control and impurity profiling in pharmaceutical manufacturing to ensure drug substance and product purity.
• Metabolite identification and drug metabolism studies to understand the biotransformation pathways of Racecadotril.
• Supporting regulatory submissions by providing reliable data for FDA, EMA, and other global health authority requirements.
• Use in stable isotope dilution analysis to achieve superior precision and accuracy over conventional analytical methods.

Basic Information

Product Name	Racecadotril-D5
CAS No.	1246815-11-1
Molecular Formula	C21H23D5NO4S
Molecular Weight	401.56 g/mol
Synonyms	Racecadotril-d5; (RS)-N-[2-([(2S,3S)-2-(Acetylsulfanylmethyl)-3-benzylpentanoyl]amino)ethyl]benzamide-d5; Acetorphan-d5; Tiorfan-d5; Benzoyl-(N-ethyl)-phenylalanyl-alanin-d5; Deuterated Racecadotril; Racecadotril Internal Standard; [D5]-Racecadotril
EINECS	Contact for details

Quality Control

Every batch of Racecadotril-D5 is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure it meets the exacting standards required for use as an internal standard. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes results for identity, purity (by HPLC), isotopic enrichment, and specific tests for residual solvents and moisture. Our quality commitment supports compliance with cGMP and ICH guidelines for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. After opening, seal the container tightly under an inert atmosphere such as argon or nitrogen to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH limits

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