Description

Clemastine Fumarate is a potent, selective histamine H1-receptor antagonist widely recognized for its anti-allergic properties. This active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of antihistamine medications. It is primarily utilized by pharmaceutical manufacturers in the production of tablets, syrups, and other formulations designed to provide relief from symptoms of allergic rhinitis, hay fever, and urticaria.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter (OTC) antihistamine medications.
• Allergy Relief Formulations: Manufacture of tablets, capsules, and oral solutions for treating seasonal and perennial allergic rhinitis.
• Antipruritic Medications: Key component in formulations aimed at relieving itching associated with hives (urticaria) and skin allergies.
• Pediatric & Adult Dosage Forms: Used in syrups and chewable tablets tailored for different age groups requiring precise dosing.
• Veterinary Pharmaceuticals: Application in veterinary medicine for managing allergic conditions in animals.
• Research & Development: Serves as a reference standard and building block in pharmacological research and new drug development.

Basic Information

Product Name	Clemastine Fumarate
CAS No.	15686-51-8
Molecular Formula	C25H30ClNO5
Molecular Weight	460.0 g/mol
Synonyms	Meclastin Fumarate; Mecloprodin Fumarate; Tavegil; Tavist; (R-(R*,R*))-1-Methyl-2-[2-[1-(4-chlorophenyl)-1-phenylethoxy]ethyl]pyrrolidine (E)-2-butenedioate; Clemastine Hydrogen Fumarate; Clemastine (E)-2-butenedioate; Fumaric Acid Clemastine Salt
EINECS	Contact for details

Quality Control

Our Clemastine Fumarate is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications, including identification, assay, and impurity profile analysis. Certificates of Analysis (COA) confirming compliance with in-house specifications are available upon request.

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 to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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