Description

Cetirizine Dihydrochloride is a high-purity, second-generation antihistamine API (Active Pharmaceutical Ingredient) essential for modern allergy and urticaria treatments. Its value lies in its potent and selective H1-receptor antagonism, offering effective symptom relief with a low incidence of sedation. This compound is critically needed by pharmaceutical manufacturers globally for the production of solid oral dosage forms, such as tablets and capsules, as well as liquid formulations.

Application

• Pharmaceutical API: Primary active ingredient in prescription and over-the-counter (OTC) allergy medications.
• Tablet Manufacturing: Direct compression or wet granulation for oral tablets.
• Capsule Filling: Used in both hard gelatin and softgel capsule formulations.
• Oral Solution/Syrup: Formulated into pediatric and adult liquid dosage forms.
• Generic Drug Production: Key component for bioequivalent generic versions of branded cetirizine products.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for finished dosage form production.
• Veterinary Pharmaceuticals: Used in certain antihistamine preparations for animal health.

Basic Information

Product Name	Cetirizine Dihydrochloride
CAS No.	83881-52-1
Molecular Formula	C21H27Cl3N2O3
Molecular Weight	461.81 g/mol
Synonyms	Cetirizine HCl; Cetirizine 2HCl; (±)-Cetirizine dihydrochloride; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride; Zyrtec (brand name active ingredient); Reactine (brand name active ingredient); Alatrol; Cetrizet
EINECS	Contact for details

Quality Control

Our Cetirizine Dihydrochloride 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, and residual solvent analysis. A Certificate of Analysis (COA) documenting full compliance with agreed specifications is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
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.