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Cetirizine Dihydrochloride
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.
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.
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
- 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
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