Description

Tianeptine Impurity CAS NO 26638-46-0 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tianeptine and its related pharmaceutical products. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for identifying and quantifying this specific impurity in Tianeptine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to ensure impurity levels are within ICH/FDA/EMA specified limits.
• Stability Studies: Employed to monitor the formation and growth of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies, degradation pathway elucidation, and synthesis process optimization for Tianeptine.

Basic Information

Product Name	Tianeptine Impurity
CAS No.	26638-46-0
Molecular Formula	C21H25ClN2O4S
Molecular Weight	436.95 g/mol
Synonyms	7-[(3-Chloro-6,11-dihydro-6-methyl-5,5-dioxodibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid; Tianeptine Related Compound; Tianeptine Metabolite; Tianeptine Acid Metabolite; S-1574 Impurity; Stablon Impurity; Coaxil Impurity; Tianeptine Carboxylic Acid
EINECS	Contact for details

Quality Control

Our Tianeptine Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and methods is provided with every shipment.

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. Avoid prolonged exposure to air.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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