Description

Ketotifen Impurity 10 Hcl (Norketotifen Hcl) is a high-purity reference standard and pharmaceutical intermediate, specifically identified as a key impurity and metabolite of the anti-allergic drug Ketotifen. This compound is critical for ensuring the quality, safety, and regulatory compliance of Ketotifen-based pharmaceutical products. It is primarily utilized by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Norketotifen in Ketotifen drug substance and finished products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for purity and stability-indicating assays.
• Metabolite Studies: Employed in pharmacokinetic and pharmacodynamic research to study the metabolism of Ketotifen.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing in GMP environments to monitor impurity levels against ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Testing: Used in forced degradation studies to understand the degradation pathways of Ketotifen.
• Chemical Synthesis Research: Acts as a building block or intermediate in the synthesis of novel chemical entities or related compounds.

Basic Information

Product Name	Ketotifen Impurity 10 Hcl (Norketotifen Hcl)
CAS No.	1227458-03-8
Molecular Formula	C19H19NOS•HCl
Molecular Weight	345.88 g/mol
Synonyms	Norketotifen Hydrochloride; 4-(1-Methyl-4-piperidylidene)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-10(9H)-one Hydrochloride; 10-Oxo-10,11-dihydrodibenzo[b,e]thiepin-4(5H)-ylidene-1-methylpiperidine Hydrochloride; Ketotifen Related Compound; Ketotifen Metabolite; Ketotifen EP Impurity; Ketotifen USP Impurity
EINECS	Contact for details

Quality Control

Our Ketotifen Impurity 10 Hcl is manufactured under strict quality control protocols to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized and tested using advanced analytical techniques, including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, ensuring compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

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