Cetirizine Dihydrochloride (Cetirizine Di-HCl)

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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 (Cetirizine Di-HCl) Uses

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.

PRODUCT KEY 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

 

  1. 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

 

  1. 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

 

  1. 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

 

  1. 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

 

  1. 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