Cetirizine Dihydrochloride

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Cetirizine Dihydrochloride is a second-generation antihistamine widely used to relieve allergy symptoms such as hay fever, urticaria (hives), and other allergic conditions. It is the dihydrochloride salt form of cetirizine, presenting as a white to off-white crystalline powder that is odorless or nearly odorless and slightly bitter in taste. Cetirizine Dihydrochloride acts as a selective antagonist of peripheral H1 histamine receptors, preventing the effects of histamine and thereby reducing allergic symptoms without causing significant sedation. It is a commonly prescribed active pharmaceutical ingredient (API) in oral tablets, syrups, and capsules.

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

Description

Table of Contents

Cetirizine Dihydrochloride

Primary Uses

Pharmaceuticals

Used as an active pharmaceutical ingredient in oral antihistamine medications for the treatment of allergic rhinitis, chronic urticaria, and other allergy-related conditions.
Incorporated into tablets, capsules, chewables, and syrups for systemic relief of allergic symptoms.
Often included in combination formulations with decongestants or other allergy symptom relievers.

Secondary Uses

Veterinary Medicine

Occasionally used off-label in veterinary medicine to treat allergic reactions and pruritus in animals.

Research & Development

Employed in pharmacological and toxicological studies related to allergy and histamine receptor activity.

KEY PRODUCT FEATURES

1. Basic Identification Attributes

Chemical Name (IUPAC): (±)-[2-[4-(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride
Common/Trade Name: Cetirizine Dihydrochloride, Cetirizine Di-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 dihydrochloride

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 due to solid form
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 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, or headache
Reactivity: Stable; avoid strong oxidizers and extreme heat

4. Storage & Handling Attributes

Storage Conditions: Store in a cool, dry place away from light and moisture
Container Type: Airtight containers, preferably amber-colored to avoid photodegradation
Shelf Life: Typically 3 to 5 years if stored correctly
Special Handling: Use standard PPE to avoid dust inhalation; avoid prolonged exposure to moisture

5. Regulatory & Compliance Attributes

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

6. Environmental & Health Impact

Ecotoxicity: Low to moderate; avoid release into aquatic environments
Persistence: Moderate persistence in environment; biodegradable under suitable conditions
Bioaccumulation: Not expected to bioaccumulate significantly
Carcinogenicity/Mutagenicity: No evidence of carcinogenic or mutagenic effects
Biodegradability: Partially biodegradable

SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

PPE: Gloves, dust mask, and safety goggles recommended when handling powder
Handling: Avoid dust generation; work in well-ventilated areas
Storage: Keep container tightly closed to prevent moisture absorption
Hygiene: Wash hands after handling; avoid ingestion and contact with eyes

First Aid Measures

Inhalation: Move to fresh air if dust inhaled; seek medical attention if respiratory irritation occurs
Skin Contact: Wash with soap and water; seek medical attention if irritation develops
Eye Contact: Rinse immediately with plenty of water for 15 minutes; consult a physician if irritation persists
Ingestion: Not acutely toxic in small amounts; if ingested in large quantities, seek medical attention immediately

Firefighting Measures

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