Description

Thiothixene Impurity 1 (CAS NO 47681-53-8) is a designated reference standard used for the analytical profiling and quality control of the antipsychotic pharmaceutical Thiothixene. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling the accurate identification and quantification of this specific process-related impurity. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory compliance teams involved in the development and manufacturing of Thiothixene and related formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Thiothixene Impurity 1 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related chromatographic techniques.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and growth of this impurity over time under various stress conditions (heat, light, humidity) to establish drug shelf life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Thiothixene, informing better formulation and packaging strategies.

Basic Information

Product Name	Thiothixene Impurity 1
CAS No.	47681-53-8
Molecular Formula	C23H29N3O2S2
Molecular Weight	443.63 g/mol
Synonyms	N,N-Dimethyl-9-[3-(4-methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide; Thiothixene Related Compound A; Thiothixene Sulfoxide; Thiothixene Impurity A; 9-[3-(4-Methylpiperazin-1-yl)propylidene]-N,N-dimethylthioxanthene-2-sulfonamide S-oxide; Z-Dimethylaminosulfonyl-2-chloro-thioxanthene; Tiotixene Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Thiothixene Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity and assigned potency, is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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