Description

Dimethindene Maleate is a potent, selective histamine H1-receptor antagonist belonging to the alkylamine class of antihistamines. This compound is of significant commercial and therapeutic importance due to its efficacy in managing allergic conditions. It is primarily utilized in the pharmaceutical industry for the formulation of anti-allergic medications. Dimethindene Maleate CAS NO 3614-69-5 is valued for its reliable performance in finished dosage forms.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in prescription and over-the-counter (OTC) anti-allergy tablets, syrups, and other oral formulations.
• Allergic Rhinitis Treatment: Formulated into medications designed to relieve symptoms such as sneezing, runny nose, and itchy eyes caused by seasonal or perennial allergies.
• Urticaria (Hives) Management: Used in topical creams, gels, or systemic treatments to reduce itching and skin inflammation associated with chronic urticaria.
• Pruritus Relief: Incorporated into dermatological preparations to alleviate itching from various skin conditions, including eczema and insect bites.
• Veterinary Pharmaceuticals: Applied in veterinary medicine for managing allergic reactions and pruritus in companion animals.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological research for developing new antihistamine compounds.

Basic Information

Product Name	Dimethindene Maleate
CAS No.	3614-69-5
Molecular Formula	C20H24N2.C4H4O4
Molecular Weight	408.47 g/mol
Synonyms	Dimethindene Maleate; Dimethindene Hydrogen Maleate; 2-[1-[2-[2-(Dimethylamino)ethyl]inden-3-yl]ethyl]pyridine maleate; Fenistil (trade name); Foristal; Dimethindenum; Dimethinden; Dimethindeni Maleas
EINECS	222-791-8

Quality Control

Our Dimethindene Maleate is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP, EP, and JP. Every batch undergoes comprehensive analytical testing to ensure identity, purity, and potency. A detailed Certificate of Analysis (COA), including results for assay, related substances, residual solvents, and heavy metals, is provided and available upon request to support your 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent degradation from atmospheric moisture. Store away from incompatible materials.

Specification

Item	Specification
Appearance	White to almost 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 (KF)	≤ 0.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with EP/USP <61> for non-sterile substances

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