Description

Tianeptine Impurity CAS NO 26638-64-2 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 the active pharmaceutical ingredient (API) Tianeptine. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, impurity profiling, and quality control. The availability of a well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements and advancing pharmaceutical research.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in Tianeptine API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product quality.
• Stability Studies: Used to track the formation of degradation products under various stress conditions to establish product shelf-life.
• Research & Development: Facilitates chemical and pharmacological research related to Tianeptine's metabolism, synthesis pathways, and impurity behavior.

Basic Information

Product Name	Tianeptine Impurity
CAS No.	26638-64-2
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; Tianeptine Metabolite; Tianeptine Acid Metabolite; S-1574 Impurity; Stablon Impurity; Coaxil Impurity
EINECS	Contact for details

Quality Control

Every batch of Tianeptine Impurity CAS 26638-64-2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance needs.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Maximum Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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