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Levocetirizine Dihydrochloride is a third-generation, highly selective H1 receptor antagonist used for the treatment of allergic conditions such as allergic rhinitis, chronic urticaria, and conjunctivitis. It is the active enantiomer of cetirizine, offering potent antihistamine activity with minimal sedation, making it suitable for daytime use.
At Bluepill Express, we manufacture and export pharmaceutical-grade Levocetirizine Dihydrochloride API that meets IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our API ensures high purity, crystalline consistency, and excellent stability, making it ideal for tablets, chewable tablets, syrups, and suspensions.
Each batch undergoes rigorous quality testing, including HPLC, IR spectroscopy, and microbial testing, ensuring reliable and consistent performance for global pharmaceutical manufacturers.
Pharmacological Information:
- Therapeutic Class: Antihistamine / H1 Receptor Antagonist
- Pharmacological Category: Non-Sedating Antihistamine
- CAS Number: 98751-31-8
- Molecular Formula: C21H25ClN2O3·HCl
- Molecular Weight: 388.90 g/mol
- Appearance: White crystalline powder
- Solubility: Freely soluble in water, slightly soluble in ethanol
- Melting Point: 176°C – 178°C
- Storage: Store in a cool, dry place below 25°C, protected from light
Mode of Action:
Levocetirizine Dihydrochloride selectively blocks peripheral H1 histamine receptors, preventing histamine-mediated allergic responses such as sneezing, itching, and nasal congestion. Its minimal penetration into the CNS reduces sedation, making it suitable for daytime use in adults and children.
Applications and Uses:
- Allergic Rhinitis – Relief of sneezing, nasal congestion, and runny nose
- Chronic Urticaria – Reduces itching, hives, and rash
- Conjunctivitis & Eye Allergies – Alleviates redness and watery eyes
- Other Histamine-Mediated Disorders – Effective in mastocytosis and angioedema
- Pharmaceutical Formulations – Tablets, chewable tablets, syrups, and suspensions
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
