Description

Azatadine Maleate (200 Mg) is a high-purity active pharmaceutical ingredient (API) belonging to the class of antihistamines. This compound is critical for its potent and selective histamine H1-receptor antagonism, providing a reliable foundation for therapeutic formulations. It is primarily required by pharmaceutical manufacturers and research institutions engaged in developing and producing anti-allergic medications and related clinical studies.

Application

• Primary API in the formulation of prescription antihistamine tablets and syrups.
• Key intermediate in advanced pharmaceutical research for new allergy and asthma therapies.
• Reference standard in quality control laboratories for analytical method development and validation.
• Active component in clinical trial materials for evaluating new dosage forms.
• Raw material for compounding pharmacies requiring specific, high-purity antihistamines.

Basic Information

Product Name	Azatadine Maleate (200 Mg)
CAS No.	3978-86-7
Molecular Formula	C20H22N2 • C4H4O4
Molecular Weight	418.48 g/mol
Synonyms	Azatadine hydrogen maleate; 11-(1-Methyl-4-piperidylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine maleate; Zadine; Idulamine; Optimine; CAS 3978-86-7; 6,11-Dihydro-11-(1-methyl-4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine maleate (1:1)
EINECS	223-613-0

Quality Control

Our Azatadine Maleate is manufactured under strict quality management systems, targeting compliance with pharmaceutical-grade standards. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling. A detailed Certificate of Analysis (COA) is provided with every shipment to ensure traceability and meet rigorous regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Heavy Metals	≤ 20 ppm

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