Description

Dexchlorpheniramine Maleate is the dextrorotatory isomer of chlorpheniramine, a potent, first-generation alkylamine-class antihistamine. This high-purity active pharmaceutical ingredient (API) is valued for its selective histamine H1-receptor antagonism, providing effective relief from allergic symptoms with a favorable potency-to-sedation profile. It is essential for pharmaceutical manufacturers developing prescription and over-the-counter (OTC) allergy, cold, and antiemetic medications. Global suppliers require a reliable source that guarantees consistent purity, stability, and full regulatory documentation to support stringent drug master file (DMF) submissions.

Application

• Pharmaceutical API: Primary use as the active ingredient in solid oral dosage forms (tablets, capsules) and liquid formulations (syrups, elixirs) for allergy relief.
• Antihistamine Preparations: Formulation of medications targeting seasonal allergic rhinitis (hay fever), perennial allergic rhinitis, vasomotor rhinitis, and allergic conjunctivitis.
• Cold & Flu Remedies: A key component in multi-symptom relief combinations for the management of sneezing, runny nose, and itchy/watery eyes associated with the common cold.
• Antiemetic Adjunct: Used in some formulations to help prevent or treat nausea and vomiting, particularly when associated with motion sickness.
• Veterinary Pharmaceuticals: Incorporated into veterinary medicinal products for managing allergic conditions in animals.
• Reference Standard: Serves as a certified reference material (CRM) for quality control laboratories performing identity, assay, and impurity testing.
• Research & Development: Utilized in biochemical research for studying histamine receptor pathways and developing new therapeutic entities.

Basic Information

Product Name	Dexchlorpheniramine Maleate
CAS No.	2438-32-6
Molecular Formula	C20H23ClN2O4
Molecular Weight	390.86 g/mol
Synonyms	(+)-Chlorpheniramine Maleate; d-Chlorpheniramine Maleate; Dexchlorpheniramine Hydrogen Maleate; Dexchlorpheniraminium Hydrogen Maleate; (3S)-3-(4-Chlorophenyl)-N,N-dimethyl-3-pyridin-2-yl-propan-1-aminium (Z)-but-2-enedioate; Polaramine (brand name); Piriton (brand name related); Dexchlorpheniramine (base)
EINECS	219-438-7

Quality Control

Our Dexchlorpheniramine Maleate is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling (related substances), residual solvents, and specific tests for heavy metals. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring full traceability and transparency. We support regulatory filings and can supply documentation relevant to CEP, DMF, or other regulatory submissions upon request.

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 nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and flow properties. Store away from incompatible materials.

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)	98.5% - 101.0% (on anhydrous basis)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Optical Rotation	+28° to +32° (c = 1 in water)
Melting Point	110°C - 115°C

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