Product Overview
Fexofenadine HCl API is a top-quality antihistamine.
It belongs to the second-generation group and is a popular choice in today’s medications.
It offers steady results and supports top standards with its effective ingredients.
Therapeutic Applications
Fexofenadine HCl API is an important ingredient in the production of allergy medications.
This API helps to formulate a specific kind of antihistamine that doesn’t cause drowsiness.
Also, it helps to manufacture products that target histamine and meet the required standards.
Specification Parameters
The high quality of Fexofenadine HCl depends on these specifications.
They set the highest standards for quality, purity, and identity in drug manufacturing.
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Chemical Name (IUPAC): (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]-α,α-dimethylbenzeneacetic acid hydrochloride
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CAS Number: 153439-40-8
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Molecular Formula: C₃₂H₃₉NO₄·HCl
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Molecular Weight: ~538.12 g/mol
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Appearance: White to off-white crystalline powder
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Identification tests: FTIR spectrum and HPLC retention time match the reference standard.
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Assay Method: HPLC
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Assay Range: 98.0% – 102.0% (on a dry basis)
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Related Substances / Impurities: Controlled by HPLC within pharmacopeial limits.
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Residual Solvents: Comply with ICH Q3C guidelines.
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Elemental Impurities: Meet ICH Q3D requirements.
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Loss on Drying / Water Content: Within specified low moisture limits.
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Microbial limits: Not applicable (N/A) or within acceptable limits for API grade.
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Solubility: Sparingly soluble in water, soluble in organic solvents.
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Melting Range: Within defined specification limits
Packaging & Storage
Fexofenadine HCl API is packed securely in strong HDPE or fibre drums.
Each bulk package usually contains 25 kg and has double-layered inner poly bags.
This setup gives strong protection, so the product stays in great condition.
For best results, keep it out of direct sunlight and heat by storing it in a shaded area.
Why Choose Us
Actiza Industry offers dependable Fexofenadine HCl API.
We ensure strong quality systems, a steady supply, and full support to meet global manufacturing and regulatory needs.
Quality Control
We produce our Fexofenadine HCl API under strict GMP rules to ensure safety and effectiveness.
Every batch of our API is thoroughly tested. It’s checked for purity, identity, and consistency.
Modern Manufacturing
We’ve got advanced facilities that handle everything from research to production.
This setup helps us monitor each step closely.
It allows us to manage risks and maintain a steady supply of APIs over time.
Complete Support
Every API batch includes clear documents like COA, MSDS, and stability data.
These records help customers meet audits, registrations, and regulatory filings with ease and confidence.
Global Supply
We’ve got flexible bulk packaging options in HDPE drums, plus reliable export services.
Our team focuses on timely deliveries. We offer competitive prices and respond quickly to customers worldwide.
