Description

Rupatadine Fumarate is a high-purity, non-sedating antihistamine and platelet-activating factor (PAF) antagonist. This active pharmaceutical ingredient (API) is critical for the development and manufacture of advanced pharmaceutical formulations targeting allergic conditions. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the production of anti-allergic medications. Our supply ensures consistent quality and reliable availability for global pharmaceutical supply chains.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of anti-allergic tablets and oral solutions.
• Allergic Rhinitis Treatment: Formulation of medications for the symptomatic relief of seasonal and perennial allergic rhinitis.
• Chronic Urticaria Management: Used in products designed for the treatment of chronic idiopathic urticaria (hives).
• Research & Development: Serves as a reference standard and key intermediate in pharmacological and clinical research.
• Generic Drug Manufacturing: Essential for companies producing generic versions of patented antihistamine drugs.
• New Drug Formulations: Exploration in novel drug delivery systems such as fast-dissolving tablets or controlled-release formulations.

Basic Information

Product Name	Rupatadine Fumarate
CAS No.	182349-12-8
Molecular Formula	C32H39ClN2O4 • C4H4O4
Molecular Weight	653.18 g/mol
Synonyms	Rupatadine Fumarate; Rupatadine Hydrogen Fumarate; 8-Chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene]-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Fumarate; UR-12592 Fumarate; UR 12592 Fumarate; Rupafin (brand name related); PAF Antagonist UR-12592
EINECS	Contact for details

Quality Control

Our Rupatadine Fumarate is manufactured under strict quality management systems. Every batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical use. A Certificate of Analysis (COA) documenting all test results is provided with each shipment. Production can be aligned with cGMP (current Good Manufacturing Practice) guidelines upon request to support regulatory filings.

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 material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider the use of desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Specific Rotation	Contact for details

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