Description

Chlorpheniramine Maleate is a high-purity active pharmaceutical ingredient (API) belonging to the alkylamine class of first-generation antihistamines. It is a critical component in the formulation of medications designed to provide rapid and effective relief from allergic symptoms. This compound is essential for manufacturers in the global pharmaceutical industry producing over-the-counter and prescription antihistamine tablets, syrups, and injectables. We supply this API to meet the stringent quality and regulatory demands of modern drug production.

Application

• Pharmaceutical API: Primary active ingredient in antihistamine medications for treating allergic rhinitis, hay fever, conjunctivitis, and urticaria.
• Oral Solid Dosage Forms: Used in the manufacture of tablets, capsules, and orally disintegrating strips for systemic allergy relief.
• Liquid Formulations: Key component in syrups, elixirs, and pediatric drops, often in combination with decongestants or analgesics.
• Injectable Solutions: Employed in parenteral formulations for rapid action in severe allergic reactions or as a pre-medication.
• Combination Cold & Flu Medications: Incorporated into multi-symptom relief products alongside analgesics, decongestants, and antitussives.
• Veterinary Pharmaceuticals: Used in antihistamine preparations for allergic conditions in animals.
• Research & Development: Serves as a reference standard and starting material in pharmacological research and new drug development.

Basic Information

Product Name	Chlorpheniramine Maleate
CAS No.	7054-11-7
Molecular Formula	C20H23ClN2O4
Molecular Weight	390.86 g/mol
Synonyms	Chlorphenamine Maleate; (+)-Chlorpheniramine Maleate; Chlor-Trimeton; Piriton; Aller-Chlor; CPM; 2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate; (3-(4-Chlorophenyl)-3-(2-pyridyl)propyl)dimethylamine maleate
EINECS	230-319-3

Quality Control

Our Chlorpheniramine Maleate is manufactured and tested to meet high-grade pharmacopeial standards, including USP and EP monographs. Every batch undergoes rigorous quality testing for identity, potency, purity, and impurity profiles using advanced analytical techniques like HPLC and GC. We provide comprehensive Certificates of Analysis (COA) with each shipment, ensuring full traceability and compliance with cGMP guidelines for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Keep away from heat, moisture, and incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (on dried basis)	98.0% - 102.0%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Optical Rotation	+18° to +22° (c = 5 in water)

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