Fexofenadine Hydrochloride is a second-generation non-sedating antihistamine widely used for the relief of allergic rhinitis, urticaria, and seasonal allergies. It is the active metabolite of terfenadine, offering a rapid onset of action and long-lasting relief from allergic symptoms without causing drowsiness.
At Bluepill Express, we manufacture and export pharmaceutical-grade Fexofenadine Hydrochloride API that complies with IP, BP, USP, and EP standards. Each batch is produced under WHO-GMP and ISO 9001:2015-certified facilities, ensuring superior purity, consistent assay, and excellent stability for global formulations.
Therapeutic Category
- Antihistamine (H1 receptor antagonist)
- Anti-allergic agent
- Non-sedative anti-histaminic
Mechanism of Action
Fexofenadine Hydrochloride works as a selective peripheral H1 receptor antagonist, blocking the action of histamine — the chemical responsible for allergy symptoms. Unlike first-generation antihistamines, it does not cross the blood-brain barrier, thus minimizing drowsiness while maintaining strong antihistaminic efficacy.
Chemical Information
| Parameter | Details |
|---|---|
| Chemical Name | (±)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid hydrochloride |
| Molecular Formula | C32H39NO4·HCl |
| Molecular Weight | 538.13 g/mol |
| CAS Number | 153439-40-8 |
| Pharmacopoeial Standards | USP / BP / EP / IP |
| Therapeutic Class | Antihistamine / Anti-allergic |
Physical & Chemical Properties
| Property | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Odor | Odorless |
| Taste | Slightly bitter |
| Solubility | Freely soluble in methanol and ethanol, slightly soluble in water |
| Melting Point | 198°C – 202°C |
| Storage | Store below 25°C, in a cool, dry, and dark place |
| Stability | Stable under normal storage and handling conditions |
Technical Specifications (Bluepill Express Standard)
| Test | Specification |
|---|---|
| Identification | Positive by IR & UV spectroscopy |
| Assay (Purity) | ≥ 99.0% (by HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.2% individual impurity |
| Heavy Metals | ≤ 10 ppm |
| Specific Optical Rotation | +15° to +20° |
| pH (1% solution) | 4.5 – 6.0 |
| Particle Size Distribution | D90 ≤ 50 µm (Micronized grade available) |
Pharmacological Applications
- Allergic Rhinitis – Reduces nasal congestion, sneezing, and runny nose
- Chronic Idiopathic Urticaria (Hives) – Provides relief from itching and redness
- Seasonal Allergy Symptoms – Controls watery eyes, nose irritation, and throat discomfort
- Non-Sedating Antihistamine Therapy – Ideal for patients requiring daytime symptom control without drowsiness
Packaging & Export Details
| Detail | Specification |
|---|---|
| Packaging Type | HDPE / Fiber drums with double poly liners |
| Available Pack Sizes | 1 kg, 5 kg, 10 kg, 25 kg |
| Labeling | Product name, batch no., MFG/EXP date, storage conditions |
| Shelf Life | 36 months (under recommended conditions) |
| Export Markets | Asia, Africa, Middle East, Latin America, Europe |
| Supply Form | Crystalline or Micronized Powder |
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (as per ICH guidelines)
- DMF / CTD support (upon request)
- Non-GMO and Allergen-free statements