Description

Racecadotril Impurity 14 is a designated impurity standard used in the analytical profiling and quality control of the antidiarrheal pharmaceutical, Racecadotril. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) and its finished dosage forms. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Racecadotril Impurity 14 in Racecadotril API and drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish and validate chromatographic methods for impurity profiling, ensuring specificity, accuracy, and precision.
• Quality Control & Batch Release Testing: Critical for routine quality control to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during the synthesis and purification of Racecadotril.

Basic Information

Product Name	Racecadotril Impurity 14
CAS No.	933680-61-6
Molecular Formula	C21H23NO4S
Molecular Weight	385.48 g/mol
Synonyms	N-[(2S)-2-[(Acetylthio)methyl]-1-oxo-3-phenylpropyl]glycine benzyl ester; (S)-Benzyl 2-(2-(acetylthio)methyl)-3-phenylpropanamido)acetate; Racecadotril Related Compound; Racecadotril Benzyl Ester Impurity; Thiorphan Benzyl Ester Acetate
EINECS	Contact for details

Quality Control

Our Racecadotril Impurity 14 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical impurity standards. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile, supporting compliance with ICH Q3A/B and current Good Manufacturing Practice (cGMP) principles.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Assay	95.0% - 105.0% (on dried basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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