Lofexidine Hydrochloride is a pharmaceutical active ingredient belonging to the central alpha-2 adrenergic agonist class. It is the hydrochloride salt of lofexidine and acts primarily by stimulating central α2-adrenergic receptors, thereby reducing sympathetic nervous-system activity. This pharmacological action has made Lofexidine Hydrochloride particularly important in pharmaceutical applications related to the management of opioid withdrawal symptoms. The FDA-approved drug product contains lofexidine as the hydrochloride salt.
Chemically, Lofexidine Hydrochloride is designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5-dihydro-1H-imidazole monohydrochloride. It has the molecular formula C₁₁H₁₂Cl₂N₂O·HCl, commonly represented as C₁₁H₁₃Cl₃N₂O, and a molecular weight of approximately 295.6 g/mol. The compound is associated with CAS No. 21498-08-8.
Lofexidine Hydrochloride is described as a white to off-white crystalline powder. According to FDA product information, it is freely soluble in water, methanol and ethanol, slightly soluble in chloroform, and practically insoluble in n-hexane and benzene. FDA development documentation reports a pH of approximately 5.1 for a 2% w/v solution, while the compound has a reported pKa of approximately 9.43 for the free base.
The pharmaceutical importance of Lofexidine Hydrochloride is primarily associated with its ability to reduce excessive noradrenergic activity during opioid withdrawal. By acting as a central α2-adrenergic agonist, it can reduce symptoms associated with increased sympathetic activity. The API is therefore relevant to pharmaceutical formulation development, analytical research, drug-development programs, quality-control testing and bulk active pharmaceutical ingredient sourcing.
MEDIOCON INC supplies Lofexidine Hydrochloride for pharmaceutical, formulation-development, analytical and research applications, subject to applicable product specifications, quality requirements, regulatory documentation and product availability. MEDIOCON INC can support customers requiring Lofexidine Hydrochloride for pharmaceutical development and bulk API sourcing, with the exact grade, assay, impurity profile, analytical requirements, packaging and documentation to be confirmed against the applicable Certificate of Analysis and product specification.
For pharmaceutical procurement, it is important to distinguish Lofexidine Hydrochloride from the Lofexidine free base. Lofexidine free base is listed under CAS 31036-80-3, whereas Lofexidine Hydrochloride is listed under CAS 21498-08-8. These are different chemical forms and should not share the same molecular-weight or salt-form information in a product database.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | ≥98.0% |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Lofexidine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC (CAS 21498-08-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Lofexidine Hydrochloride API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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