Description

Cetirizine is a highly selective, second-generation histamine H1-receptor antagonist widely recognized for its efficacy in managing allergic conditions. Its primary value lies in providing potent, long-lasting relief from allergy symptoms with a low incidence of sedation, making it a cornerstone in pharmaceutical formulations. This active pharmaceutical ingredient (API) is essential for manufacturers in the global pharmaceutical industry producing prescription and over-the-counter (OTC) antihistamine medications.

Application

• Pharmaceutical API: Primary active ingredient in tablet, capsule, syrup, and orally disintegrating tablet (ODT) formulations for systemic allergy treatment.
• Seasonal Allergic Rhinitis Treatment: Manufacture of medications for relieving symptoms such as sneezing, rhinorrhea, and itchy/watery eyes caused by pollen and other seasonal allergens.
• Perennial Allergic Rhinitis Management: Production of drugs for year-round allergy symptoms triggered by indoor allergens like dust mites, mold, and pet dander.
• Chronic Urticaria Therapy: Key component in medications designed to reduce itching and the number of hives in patients with chronic idiopathic urticaria.
• Pediatric Allergy Formulations: Used in developing child-friendly dosage forms, including oral solutions and syrups, due to its established safety profile.
• Combination Drug Products: Utilized in fixed-dose combination therapies, often paired with decongestants like pseudoephedrine for enhanced symptom relief.
• Generic Drug Manufacturing: Critical raw material for producing bioequivalent generic versions of branded cetirizine products for global markets.

Basic Information

Product Name	Cetirizine
CAS No.	83881-51-0
Molecular Formula	C21H25ClN2O3
Molecular Weight	388.89 g/mol
Synonyms	Cetirizine Dihydrochloride; (±)-Cetirizine; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid; Zyrtec (Brand Name); Reactine (Brand Name); Aller-Tec; CZP; PM 381
EINECS	Contact for details

Quality Control

Our Cetirizine is manufactured under strict quality management systems to ensure it meets the highest standards for pharmaceutical use. Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, in compliance with major pharmacopoeial standards such as USP, EP, and BP. A detailed Certificate of Analysis (COA) is provided with every shipment, guaranteeing traceability and consistent purity, typically ≥99.0%.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent absorption of atmospheric moisture, which could affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Related Substances (HPLC)	Total impurities: NMT 0.5% Any individual impurity: NMT 0.1%
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.