Description

Ketotifen n-Oxide Hydrochloride is a key pharmaceutical intermediate and metabolite of the well-known anti-allergic agent Ketotifen. This compound is of significant importance for research and development in the pharmaceutical industry, particularly for analytical method development, metabolism studies, and impurity profiling. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the development and quality control of antihistamine and mast cell stabilizer medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ketotifen and its related substances in drug products and active pharmaceutical ingredients (APIs).
• Metabolite Research: Critical for in-vitro and in-vivo metabolism studies to understand the pharmacokinetic profile and metabolic pathways of Ketotifen.
• Impurity Synthesis and Profiling: Used in the synthesis and characterization of specified impurities and degradation products to support regulatory filings (e.g., ICH guidelines) and ensure drug safety.
• Analytical Method Development: Employed as a standard for developing and validating high-performance liquid chromatography (HPLC), LC-MS, and other analytical techniques.
• Pharmacological Research: Used in biochemical assays to study the structure-activity relationship (SAR) and mechanism of action of Ketotifen derivatives.

Basic Information

Product Name	Ketotifen n-Oxide Hydrochloride
CAS No.	59743-91-8
Molecular Formula	C19H20NO3S · HCl
Molecular Weight	385.89 g/mol
Synonyms	4-(1-Methyl-4-piperidylidene)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-10(9H)-one N-Oxide Hydrochloride; Ketotifen N-Oxide HCl; Ketotifen Impurity F (N-Oxide); Ketotifen Metabolite N-Oxide Hydrochloride; 9,10-Dihydro-4-(1-methyl-4-piperidinylidene)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one 1-Oxide Hydrochloride; ZK 59743-91-8; Zaditen N-Oxide Hydrochloride
EINECS	Contact for details

Quality Control

Our Ketotifen n-Oxide Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets high-purity standards suitable for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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