Description

Lofexidine Hydrochloride is a highly selective α-2 adrenergic receptor agonist. This compound is of significant commercial and therapeutic importance as the first non-opioid medication approved by the U.S. FDA for the mitigation of opioid withdrawal symptoms. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of addiction treatment therapies and central nervous system (CNS) active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for managing acute opioid withdrawal symptoms (e.g., Lucemyra®).
• Clinical Research: Utilized in preclinical and clinical studies investigating new applications for α-2 adrenergic agonists.
• Drug Formulation: Serves as a key raw material for formulating tablets, capsules, or other solid oral dosage forms in GMP facilities.
• Reference Standard: Used as a high-purity chemical reference standard in analytical laboratories for quality control and method validation.
• Biochemical Research: Employed in studies of adrenergic receptor function and signal transduction pathways within the CNS.

Basic Information

Product Name	Lofexidine Hydrochloride
CAS No.	21498-08-8
Molecular Formula	C11H13Cl2N3O • HCl
Molecular Weight	295.61 g/mol
Synonyms	Lofexidine HCl; 2-[1-(2,6-Dichlorophenoxy)ethyl]-4,5-dihydro-1H-imidazole Hydrochloride; BritLofex; Lucemyra (brand name); LFX; Lofexidini Hydrochloridum; BA-168; RMI-14042A
EINECS	Contact for details

Quality Control

Our Lofexidine Hydrochloride is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) detailing identity, purity, and impurity profiles are provided with each batch. We can support development with material compliant with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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