Description

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

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Tianeptine Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: A critical component in developing and validating HPLC, UPLC, or GC methods for Tianeptine analysis.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Tianeptine Impurity E
CAS No.	768351-55-9
Molecular Formula	C21H25ClN2O4S
Molecular Weight	436.95 g/mol
Synonyms	7-[(3-Chloro-6,11-dihydro-6-methyl-5,5-dioxido-5λ⁶-dibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid; Tianeptine Related Compound E; Tianeptine EP Impurity E; Tianeptine USP Impurity E; TIANEPTINE IMPURITY E CRS; Stablon Impurity E
EINECS	Contact for details

Quality Control

Every batch of Tianeptine Impurity E is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitable for use as a pharmaceutical reference standard.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.