Description

Temelastine CAS NO 86181-42-2 is a selective histamine H1-receptor antagonist belonging to the benzimidazole class of compounds. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of advanced antihistamine therapeutics. It is primarily utilized by pharmaceutical R&D laboratories and manufacturers engaged in the production of novel allergy and inflammation medications.

Application

• Primary Pharmaceutical Ingredient: Serves as the core active component in the formulation of prescription antihistamine drugs.
• Allergy Medication R&D: Used in preclinical and clinical research for developing new treatments for allergic rhinitis, chronic urticaria, and other histamine-mediated conditions.
• Reference Standard: Employed as an analytical standard in quality control laboratories for method development, validation, and impurity profiling.
• Mechanistic Studies: A vital tool in pharmacological research for studying H1-receptor binding kinetics and signal transduction pathways.
• Formulation Development: Used in the development of various dosage forms, including tablets, capsules, and controlled-release systems.
• Process Chemistry: Acts as a key intermediate or final product in sophisticated organic synthesis routes within GMP environments.

Basic Information

Product Name	Temelastine
CAS No.	86181-42-2
Molecular Formula	C20H21N3O2
Molecular Weight	335.40 g/mol
Synonyms	1-Methyl-2-[3-(1-pyrrolidinylmethyl)phenoxy]methylbenzimidazole; Temelastine; KB-2413; E-0659; 1-Methyl-2-[[[3-(1-pyrrolidinylmethyl)phenoxy]methyl]-1H-benzimidazole; UNII-9E5N5G5Y5J
EINECS	Contact for details

Quality Control

Our Temelastine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical development. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, detailing results from tests including HPLC assay, related substances, residual solvents, and heavy metals.

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). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

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)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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