Description

Racecadotril Diacid Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of Racecadotril, an antidiarrheal medication. This high-purity impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily utilized by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying the diacid-related impurity in Racecadotril active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods.
• Quality Control and Release Testing: Essential for routine batch analysis to ensure Racecadotril products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., hydrolytic, oxidative) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Used by chemists to study and optimize the synthesis pathway of Racecadotril, aiming to minimize the formation of this impurity.

Basic Information

Product Name	Racecadotril Diacid Impurity
CAS No.	141437-87-8
Molecular Formula	C21H23NO5
Molecular Weight	369.41 g/mol
Synonyms	N-[(2S)-2-[(Acetylthio)methyl]-1-oxo-3-phenylpropyl]glycine; Racecadotril Acid Impurity; Racecadotril Diacid; (2S)-2-[(Acetylsulfanyl)methyl]-3-phenylpropanoic acid (glycine derivative); Thiorphan Diacid; Acetorphan Diacid; S-Acetylthiorphan Diacid; Racecadotril Related Compound
EINECS	Contact for details

Quality Control

Our Racecadotril Diacid Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS characterization. We adhere to relevant ICH Q3A/B guidelines and can support compliance with cGMP standards for pharmaceutical reference materials.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
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.