FEXOFENADINE HYDROCHLORIDE

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FEXOFENADINE HYDROCHLORIDE

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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

ParameterDetails
Chemical Name(±)-4-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylbenzeneacetic acid hydrochloride
Molecular FormulaC32H39NO4·HCl
Molecular Weight538.13 g/mol
CAS Number153439-40-8
Pharmacopoeial StandardsUSP / BP / EP / IP
Therapeutic ClassAntihistamine / Anti-allergic

Physical & Chemical Properties

PropertySpecification
AppearanceWhite to off-white crystalline powder
OdorOdorless
TasteSlightly bitter
SolubilityFreely soluble in methanol and ethanol, slightly soluble in water
Melting Point198°C – 202°C
StorageStore below 25°C, in a cool, dry, and dark place
StabilityStable under normal storage and handling conditions

Technical Specifications (Bluepill Express Standard)

TestSpecification
IdentificationPositive 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 DistributionD90 ≤ 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

DetailSpecification
Packaging TypeHDPE / Fiber drums with double poly liners
Available Pack Sizes1 kg, 5 kg, 10 kg, 25 kg
LabelingProduct name, batch no., MFG/EXP date, storage conditions
Shelf Life36 months (under recommended conditions)
Export MarketsAsia, Africa, Middle East, Latin America, Europe
Supply FormCrystalline 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

BLUEPILL EXPORT is a pharmaceutical exporter from India supplying Active Pharmaceutical Ingredients (APIs), finished formulations, nutraceuticals, and contract manufacturing solutions to pharmaceutical distributors, importers, wholesalers, and healthcare businesses worldwide.

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