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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.
Description
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
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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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