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Cetrizine HCl Structure

Product Type

API

Grade

BP/USP

Chemical Formula

C21H27Cl3N2O3

IUPAC Name

2-(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid dihydrochloride

CAS No.

83881-52-1

Molecular Weight

461.81 g/mol

Chemical Class

Diphenylmethanes

Therapeutic Class

Histamine H1 Antagonists

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance White to off-white, crystalline powder
Solubility Freely soluble in water, practically insoluble in acetone and in methylene chloride, solubility in ethanol is very low.
Melting point 110–115°C
pH 4.0 to 5.0

Product Description

Cetirizine HCl, also commonly known as Zyrtec, is an orally active second-generation histamine H1 antagonist proven effective in the treatment of various allergic symptoms, such as sneezing, coughing, nasal congestion, hives, and other symptoms.
One of the most common uses for this drug is for a condition called allergic rhinitis. The prevalence of allergic rhinitis in the United States is about 15% according to physician diagnoses, and up to 30%, according to self-reported nasal symptoms. Allergic rhinitis is associated with multiple missed or unproductive days at work and school, problems with sleep, and other difficulties with day-to-day activities for many individuals.

How Cetrizine HCl Works

Cetirizine, a metabolite of hydroxyzine, is an antihistamine drug. Its main effects are achieved through selective inhibition of peripheral H1 receptors. The antihistamine activity of cetirizine has been shown in a variety of animal and human models. In vivo and ex vivo animal models have shown insignificant anticholinergic and anti-serotonergic effects. In clinical studies, however, dry mouth was found to be more frequent with cetirizine than with a placebo. In vitro receptor binding studies have demonstrated no detectable affinity of cetirizine for histamine receptors other than the H1 receptors. Studies with radiolabeled cetirizine administration in the rat have demonstrated insignificant penetration into the brain. Ex vivo studies in the mouse have shown that systemically administered cetirizine does not occupy cerebral H1 receptors significantly.

Use(s)

Adverse Effects

Why choose Salius for Cetrizine HCl?

  1. Trusted Manufacturing with Global Quality Standards
    Salius complies with WHO-GMP across all facilities, with select sites also approved by the U.S. FDA. Every batch undergoes rigorous laboratory testing to guarantee safety, quality, and full regulatory compliance.
  2. Large-Scale API Production with Competitive Pricing
    Leveraging extensive manufacturing capacity and efficient global distribution, Salius delivers high-quality APIs at competitive prices, supporting pharmaceutical companies in cost-sensitive markets worldwide.
  3. Global Export Expertise and Comprehensive Documentation Support
    Salius has experience exporting APIs worldwide, offering full regulatory documentation including Drug Master Files (DMF) and impurity profiles. We provide dedicated support for regulatory filings to help international clients, even in highly regulated markets, ensure smooth approval and compliance.
  4. Documents We Provide
  5. Proven Reliability
    Salius Pharma is presented as a government-recognized star export house with strong quality and delivery ratings.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO-GMP, ISO 9001:2015, FDA-audited facilities
Affordability & Generic Access Cost-competitive generics for global supply
Export Experience Proven record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

Cetirizine HCl is commonly used to treat allergic conditions such as allergic rhinitis (hay fever), chronic idiopathic urticaria (hives), and other symptoms related to seasonal or perennial allergies. It is widely used in respiratory and dermatological therapy, particularly for its antihistaminic effects.

Salius Pharma facilitates market entry by providing regulatory documents such as Drug Master Files (DMFs), Certificates of Analysis (CoAs), and CTD/eCTD dossiers, tailored to meet the requirements of authorities like PPB (Kenya), BPOM (Indonesia), DIGEMID (Peru), and SFDA (Saudi Arabia).

Prolonged use should be monitored, particularly in patients with renal or hepatic impairment, due to the potential for drug accumulation. While Cetirizine HCl is generally well tolerated, long-term use may result in reduced effectiveness or mild side effects such as drowsiness. Chronic use should be clinically justified and supervised by a healthcare provider.

Cetirizine HCl is a second-generation antihistamine that selectively inhibits peripheral H1 histamine receptors. This action helps relieve symptoms such as sneezing, itching, nasal congestion, and hives by preventing the effects of histamine released during allergic reactions. It causes minimal sedation due to limited penetration of the blood–brain barrier.

Common side effects include drowsiness, dry mouth, fatigue, and headache. Infrequently, gastrointestinal discomfort or hypersensitivity reactions such as rash may occur. Serious side effects are rare but may include allergic reactions requiring medical attention.

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Looking to source Cetrizine HCl or other high-quality pharmaceutical products? We’re here to help. Whether you need Active Pharmaceutical Ingredients (APIs), finished formulations, or regulatory support, our team is ready to provide dependable, compliant, and cost-effective solutions tailored to your market needs.

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