Description

Terfenadine is a selective, non-sedating histamine H1-receptor antagonist. It is a key pharmaceutical intermediate and active pharmaceutical ingredient (API) of significant historical importance in the development of second-generation antihistamines. This compound is essential for manufacturers in the pharmaceutical industry engaged in research, development, and production of allergy and respiratory medications.

Application

• Pharmaceutical API Synthesis: Primary use as the active ingredient in the manufacture of antihistamine formulations.
• Reference Standard: Serves as a high-purity standard for quality control and analytical method development in regulatory and laboratory settings.
• Biochemical Research: Used in pharmacological studies to investigate H1-receptor antagonism and related pathways.
• Generic Drug Production: Critical for companies producing generic versions of antihistamine medications.
• Precursor Chemical: Acts as a starting material or intermediate in the synthesis of more complex pharmaceutical molecules.

Basic Information

Product Name	Terfenadine
CAS No.	50679-08-8
Molecular Formula	C32H41NO2
Molecular Weight	471.67 g/mol
Synonyms	α-(4-(1,1-Dimethylethyl)phenyl)-4-(hydroxydiphenylmethyl)-1-piperidinebutanol; (±)-1-(p-tert-Butylphenyl)-4-[4-(α-hydroxy-α-phenylbenzyl)piperidino]butanol; (±)-Terfenadine; MDL 991; RMI 9918; Triludan; Teldane; Seldane; Allerplus; Ternadine
EINECS	256-652-7

Quality Control

Our Terfenadine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profile analysis via HPLC, to ensure it meets high-purity standards suitable for pharmaceutical applications. A Certificate of Analysis (COA) detailing all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water (KF Titration)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.