Description

Rupatadine CAS NO 156611-76-6 is a potent, second-generation antihistamine and platelet-activating factor (PAF) antagonist. This dual mechanism of action makes it a highly effective active pharmaceutical ingredient (API) for managing allergic conditions. It is primarily utilized by pharmaceutical manufacturers in the research, development, and production of prescription medications targeting allergic rhinitis and chronic urticaria.

Application

• Pharmaceutical API: Core active ingredient in the formulation of oral tablets and other dosage forms for the treatment of allergic disorders.
• Allergic Rhinitis Medication: Used in drugs designed to relieve symptoms such as sneezing, runny nose, and itchy eyes caused by seasonal or perennial allergies.
• Chronic Urticaria Treatment: Incorporated into therapeutic products for managing the symptoms of chronic spontaneous hives.
• Research & Development: Serves as a critical reference standard and intermediate in preclinical and clinical studies for new allergy therapies.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent generic versions of branded rupatadine medications.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished drug products.

Basic Information

Product Name	Rupatadine
CAS No.	156611-76-6
Molecular Formula	C26H26ClN3
Molecular Weight	415.96 g/mol
Synonyms	8-Chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene]-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Rupafin; Rupatadine Fumarate (salt form); UR-12592; PAF Antagonist UR-12592
EINECS	Contact for details

Quality Control

Our Rupatadine API is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by IR and NMR, to ensure it meets stringent pharmacopeial standards. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm

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