CETIRIZINE DIHYDROCHLORIDE

Cetirizine Dihydrochloride is a second-generation antihistamine widely used for the relief of allergy symptoms, including rhinitis, conjunctivitis, urticaria, and other histamine-mediated conditions. It acts as a selective H1 receptor antagonist, providing effective symptom relief with minimal sedation compared to first-generation antihistamines.

At Bluepill Express, we manufacture and export pharmaceutical-grade Cetirizine Dihydrochloride API that complies with IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our API ensures high purity, stable crystalline form, and consistent particle size, making it suitable for tablets, capsules, syrups, and chewable formulations.

Each batch undergoes stringent quality testing, including HPLC, IR spectroscopy, and microbial testing, ensuring reliable performance for global pharmaceutical manufacturers.

Pharmacological Information:

• Therapeutic Class: Antihistamine / H1 Receptor Antagonist
• Pharmacological Category: Non-Sedating Antihistamine
• CAS Number: 83881-51-0
• Molecular Formula: C21H25ClN2O3·2HCl
• Molecular Weight: 461.82 g/mol
• Appearance: White to off-white crystalline powder
• Solubility: Freely soluble in water, slightly soluble in ethanol
• Melting Point: 256°C – 258°C
• Storage: Store in a cool, dry place below 25°C, protected from light

Mode of Action:

Cetirizine Dihydrochloride selectively blocks peripheral H1 histamine receptors, preventing histamine-mediated allergic responses such as sneezing, itching, and nasal congestion. Its minimal CNS penetration reduces sedation, making it suitable for daytime use.

Applications and Uses:

• Allergic Rhinitis – Relief of sneezing, runny nose, and nasal congestion
• Chronic Urticaria – Reduces itching and rash
• Conjunctivitis & Eye Allergies – Alleviates redness and watery eyes
• Other Histamine-Mediated Disorders – Effective in mastocytosis and angioedema
• Pharmaceutical Formulations – Tablets, chewable tablets, capsules, syrups, and suspension forms

Technical Specifications:

• Assay (Purity): ≥ 99.0%
• Identification: IR spectrum matches reference standard
• Loss on Drying: ≤ 0.5%
• Residue on Ignition: ≤ 0.1%
• Heavy Metals: ≤ 10 ppm
• Particle Size: Optimized for uniform dissolution and blending
• Related Substances: ≤ 0.2% (individual impurity)
• Microbial Limits: Complies with pharmacopeial standards

Manufacturing & Quality Assurance – Bluepill Express:

• Produced under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
• High-purity crystalline API suitable for oral dosage forms
• COA, MSDS, and TDS provided with each batch
• HPLC-tested for purity, stability, and impurity profiling
• Pharmacopeial compliance: IP / BP / USP / EP

Packaging & Export Details:

• Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with inner liner
• Shelf Life: 36 months from manufacturing date
• Labeling: Export-compliant with batch number and origin
• Export Markets: Africa, Asia, Europe, Middle East, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Stability Data (on request)
  • Non-GMO & Allergen-Free Declarations