Description

Clemastine Fumarate CAS NO 14976-57-9 is a potent, selective histamine H1-receptor antagonist widely recognized for its anti-allergic properties. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of antihistamine medications for the treatment of allergic conditions such as hay fever, urticaria, and allergic rhinitis.

Application

• Pharmaceutical API: Primary active ingredient in prescription and over-the-counter (OTC) antihistamine tablets, syrups, and injectables.
• Allergy Medication Production: Formulation of medications for symptomatic relief of seasonal and perennial allergies.
• Antipruritic Formulations: Used in creams or oral medications to relieve itching associated with skin allergies and hives.
• Veterinary Pharmaceuticals: Component in antihistamine preparations for allergic conditions in animals.
• Clinical Research: Reference standard and biochemical tool for pharmacological studies on histamine receptors and allergic response mechanisms.
• Generic Drug Manufacturing: Sourcing of API for the production of bioequivalent generic versions of branded antihistamine drugs.

Basic Information

Product Name	Clemastine Fumarate
CAS No.	14976-57-9
Molecular Formula	C25H30ClNO5
Molecular Weight	460.0 g/mol
Synonyms	Clemastine Hydrogen Fumarate; (+)-(2R)-2-[2-[(R)-1-(4-Chlorophenyl)-1-phenylethoxy]ethyl]-1-methylpyrrolidine (E)-but-2-enedioate; Meclastin Fumarate; Tavegil® (brand name); Tavegyl; Tavist; 1-Methyl-2-[2-[(R)-1-(p-chloro-α-phenylbenzyl)oxy]ethyl]pyrrolidine (E)-2-butenedioate; Aller-Eze; Clemastine (base)
EINECS	239-064-3

Quality Control

Our Clemastine Fumarate is manufactured under strict quality management systems. Each batch is tested to ensure compliance with major pharmacopoeial standards such as USP, EP, and BP for identity, purity, and potency. Comprehensive testing includes assay, related substances, residual solvents, and microbiological examination. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and regulatory compliance for our global pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbial Limits	Conforms to EP/USP requirements

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