FEXOFENADINE HYDROCHLORIDE

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