Description

Racecadotril Impurity 15 is a designated impurity standard used in the analytical profiling and quality control of the antidiarrheal pharmaceutical agent, Racecadotril. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Racecadotril Impurity 15 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: A critical component for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurities in Racecadotril synthesis.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Racecadotril API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Racecadotril synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Racecadotril Impurity 15
CAS No.	13261-70-6
Molecular Formula	C21H23NO4
Molecular Weight	353.41 g/mol
Synonyms	N-[2-[(Acetylthio)methyl]-1-oxo-3-phenylpropyl]glycine Benzyl Ester; (2S)-2-[(2S)-2-(Benzyloxycarbonylamino)-3-phenylpropanamido]-4-(methylsulfanyl)butanoic Acid; Racecadotril Related Compound; Thiorphan Benzyl Ester Derivative; Acetorphan Impurity; Enkephalinase Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Racecadotril Impurity 15 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and related substances. Our quality system supports compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.