Pharm-Rx Fexofenadine HCL USP

Identification & Functionality

Chemical Name

Fexofenadine Hydrochloride

Molecular formula

C₃₂H₃₉NO₄ . HCl

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors

Active Pharmaceutical Ingredients (APIs)

Definition

Fexofenadine Hydrochloride contains NLT 98.0% and NMT 102.0% of fexofenadine hydrochloride (C₃₂H₃₉NO₄ · HCl), calculated on the anhydrous basis.

Chemical Structure

Properties

Typical Properties

	Value	Units	Test Method / Conditions
Molecular Weight	538.12	—	—

Regulatory & Compliance

Certifications & Compliance

United States Pharmacopeia (USP)

USP Reference Standards

• USP Fexofenadine Hydrochloride RS
• USP Fexofenadine Related Compound A RS
• 2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl] butanoyl}phenyl)-2-methylpropanoic acid; Also known as Benzeneacetic acid, 4-[1-oxy-4-[4- (hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl. C₃₂H₃₇NO₄ 499.65
• USP Fexofenadine Related Compound B RS
• 3-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl benzeneacetic acid hydrochloride monohydrate; Also known as 2-(3-{1-Hydroxy-4-[4- (hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)- 2-methylpropanoic acid hydrochloride monohydrate. (ERR 1-Feb-2021) C₃₂H₃₉NO₄ · HCl · H₂O 556

Storage & Handling

Storage Information

Preserve in well-closed, light-resistant containers, and store at controlled room temperature.