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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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Description

Cetirizine Hydrochloride

Primary Uses 

  1. 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 

  1. Veterinary Medicine
  • Occasionally used off-label for allergy treatment in animals under veterinary supervision.
  1. 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

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