Cetirizine Hydrochloride Amaris Chemicals

Cetirizine Hydrochloride

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Cetirizine Hydrochloride is a widely used second-generation antihistamine effective for treating allergic conditions such as allergic rhinitis, chronic urticaria, and other allergy symptoms. It is the hydrochloride salt form of cetirizine, existing as a white to off-white crystalline powder with a slightly bitter taste. Cetirizine HCl acts by selectively blocking peripheral H1 histamine receptors, thereby reducing allergic symptoms without significant sedation or central nervous system depression. It is commonly formulated into tablets, syrups, and capsules as an active pharmaceutical ingredient.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Allergy relief ingredient, Antihistamine, Cetirizine hydrochloride, Pharmaceutical active ingredient, White crystalline powder

Description

Table of Contents

Cetirizine Hydrochloride

Primary Uses

Pharmaceuticals

Used as an active pharmaceutical ingredient in antihistamine medications for treatment of seasonal and perennial allergic rhinitis.
Employed in formulations for chronic idiopathic urticaria (hives) relief.
Incorporated in oral dosage forms like tablets, chewable tablets, capsules, and syrups.
Used in combination with decongestants and other allergy symptom relievers in multi-ingredient products.

Secondary Uses

Veterinary Medicine

Occasionally used off-label for allergy treatment in animals under veterinary supervision.

Research and Development

Used in pharmacological research to study H1 receptor antagonists and allergy mechanisms.

KEY PRODUCT FEATURES

1. Basic Identification Attributes

Chemical Name (IUPAC): (±)-[2-[4-(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid hydrochloride
Common/Trade Name: Cetirizine Hydrochloride, Cetirizine HCl
CAS Number: 83881-51-0
HS Code: 2933.29.90
Molecular Formula: C21H25Cl2N2O3
Molecular Weight: 461.35 g/mol
Synonyms:
- Cetirizine HCl
- 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid hydrochloride

2. Physical & Chemical Properties

Physical State: White to off-white crystalline powder
Color & Odor: White; odorless or slight characteristic odor
Melting Point: Approximately 223–225°C (decomposes)
Boiling Point: Not applicable (decomposes)
Density: Not typically specified
Solubility:
- Freely soluble in water
- Soluble in ethanol and methanol
- Practically insoluble in ether and chloroform
pH (1% aqueous solution): Approximately 3.5 to 5.0
Stability: Stable under normal storage conditions; sensitive to moisture and heat

3. Safety & Hazard Attributes

Hazard Class (GHS): Not classified as hazardous under normal handling
NFPA Ratings:
- Health: 1
- Flammability: 0
- Reactivity: 0
Exposure Limits: No specific occupational exposure limit established
Toxicity: Low toxicity at therapeutic doses; overdose can cause sedation, dry mouth, headache
Reactivity: Stable; avoid strong oxidizers and extreme heat

4. Storage & Handling Attributes

Storage Conditions: Store in a cool, dry, well-ventilated area away from light and moisture
Container Type: Airtight, preferably amber-colored containers to prevent photodegradation
Shelf Life: Typically 3 to 5 years if stored properly
Special Handling: Use appropriate PPE; avoid dust formation and inhalation

5. Regulatory & Compliance Attributes

Pharmacopoeial Status: Included in USP, BP, EP, JP, and other major pharmacopoeias
FDA Status: Approved active pharmaceutical ingredient
REACH Status: Registered
Transportation: Not regulated as hazardous material
Waste Disposal: Dispose according to pharmaceutical and local environmental regulations

6. Environmental & Health Impact

Ecotoxicity: Low to moderate; avoid aquatic release
Persistence: Moderately persistent; biodegradable under certain conditions
Bioaccumulation: Not expected to bioaccumulate significantly
Carcinogenicity/Mutagenicity: No evidence of carcinogenic or mutagenic effects
Biodegradability: Partial biodegradability

SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

PPE: Gloves, protective goggles, dust mask or respirator if handling powder in bulk
Handling: Avoid dust generation; handle in well-ventilated areas
Storage: Keep container tightly closed to prevent moisture uptake
Hygiene: Wash hands after handling; avoid ingestion and contact with eyes

First Aid Measures

Inhalation: Move to fresh air; seek medical attention if respiratory irritation occurs
Skin Contact: Wash thoroughly with soap and water; consult a doctor if irritation persists
Eye Contact: Flush with water for at least 15 minutes; seek medical advice if irritation continues
Ingestion: Not highly toxic; in case of overdose, seek medical attention immediately

Firefighting Measures

Fire Hazards: Not highly flammable; may decompose on heating, releasing toxic fumes
Extinguishing Media: Use water spray, foam, dry chemical, or CO₂
Special Precautions: Firefighters should wear protective clothing and self-contained breathing apparatus
Decomposition Products: Carbon monoxide, carbon dioxide, hydrogen chloride, nitrogen oxides