Description

Setastine is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) of significant commercial importance. This compound is primarily valued for its role as a key building block in the synthesis of advanced antihistamine medications. It is essential for manufacturers in the pharmaceutical and fine chemical industries seeking reliable, high-quality raw materials for research, development, and production. Our supply of Setastine CAS NO 64294-95-7 meets stringent quality standards to ensure consistency and efficacy in final drug formulations.

Application

• Pharmaceutical API Synthesis: Primary use as an intermediate in the production of non-sedating antihistamine drugs.
• Research & Development: Serves as a critical reference standard and starting material in medicinal chemistry and pharmacology research.
• Fine Chemical Manufacturing: Used in the synthesis of complex organic molecules requiring a specific piperidine derivative structure.
• Contract Manufacturing Organizations (CMOs): Supplied to CMOs for the production of generic and proprietary pharmaceutical formulations.
• Analytical Standard: Employed as a high-purity standard in quality control (QC) and quality assurance (QA) laboratories for HPLC, GC, and spectroscopic analysis.

Basic Information

Item	Detail
Product Name	Setastine
CAS No.	64294-95-7
Molecular Formula	C20H21NO2
Molecular Weight	307.39 g/mol
Synonyms	1-[(4-Fluorophenyl)methyl]-4-piperidinyl 1H-Benzimidazole-2-carboxylate; 1-[(4-Fluorobenzyl)-4-piperidyl] benzimidazol-2-ylcarbamate; Setastine Hydrochloride (salt form precursor); Loderix; WAL 801 CL; AHR-11325; CAS 64294-95-7
EINECS	Contact for details

Quality Control

Our Setastine is manufactured under strict quality management systems. Every batch undergoes comprehensive analytical testing, including HPLC for purity, IR and NMR for structural confirmation, and tests for residual solvents and heavy metals. We provide a Certificate of Analysis (COA) with each shipment, detailing all specifications and results. Our quality protocols are designed to support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopeial standards for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider using a desiccant.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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