Overview
Fexofenadine hydrochloride (CAS 153439-40-8 ), marketed under the brand name Allegra, is a second-generation antihistamine active pharmaceutical ingredient used in the manufacture of prescription and OTC allergy relief products.
It targets peripheral H1 receptors without significant CNS penetration, making it a preferred API for non-sedating antihistamine formulations. The primary use is in finished oral dosage forms such as tablets and capsules.
These products are indicated for seasonal allergic rhinitis and chronic idiopathic urticaria. Contract manufacturers and generic drug producers source it as the active ingredient in branded and private-label antihistamine products.
In personal care, it is evaluated for inclusion in topical formulations targeting skin hypersensitivity and allergic dermatitis responses. Pharmaceutical formulators also utilize it in pediatric oral suspension development.
Precise particle size and solubility profiles influence grade selection for these liquid applications. Fexofenadine hydrochloride is supplied as a white to off-white crystalline powder for industrial use.
It is available in USP , BP , and Ph. Eur. compendial grades to meet regulatory requirements across major markets. Bulk quantities are typically offered for large scale pharmaceutical manufacturing.
Micronized grades are available to support specific dissolution and bioavailability targets. This ensures the API meets the rigorous standards required for modern drug delivery systems and patient safety protocols.
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Physical Properties
| Melting Point | 168.9 °C |
| Appearance | Off-White Crystalline Solid |
| Color | white to beige |
| Form | powder |
Safety & Handling
Danger GHS07 GHS08 Hazard Statements H302 Harmful if swallowed H312 Harmful in contact with skin H315 Causes skin irritation H317 May cause an allergic skin reaction H319 Causes serious eye irritation H335 May cause respiratory irritation H360 May damage fertility or the unborn child Precautionary Statements P203 Obtain, consult and follow expert instructions for use. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P264 Wash … thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves/protective clothing/eye protection/face protection. P317 Get emergency medical help. P318 IF exposed or concerned, get medical advice. P319 Get medical advice/attention if you feel unwell. P321 Specific treatment (see … on this label). P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents/container in accordance with local regulations. P264+P265 Wash … thoroughly after handling. P301+P317 Get emergency medical help. P302+P352 IF ON SKIN: Wash with plenty of water. P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P332+P317 Get emergency medical help. P333+P317 Get emergency medical help. P337+P317 If eye irritation persists: Get medical advice/attention. Get emergency medical help. P362+P364 Take off contaminated clothing and wash it before reuse. P403+P233 Store in a well-ventilated place. Keep container tightly closed. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Trade & Regulatory
| HS Code | 2933399090 |
| WGK (Germany) | 3 |
Other Names
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Chemical Properties
- CAS Number
- 153439-40-8
- EC Number
- 604-906-2
- Mol. Weight
- 538.1
- HS Code
- 2933399090
- Category
- Pharmaceutical Intermediates