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Cetirizine Hydrochloride
PHARMACEUTICAL GRADE

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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Description

Cetirizine Dihydrochloride

Primary Uses 

  1. 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 

  1. Veterinary Medicine
  • Occasionally used off-label in veterinary medicine to treat allergic reactions and pruritus in animals.
  1. 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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