Description

Lofexidine-D4 Hydrochloride CAS NO 78302-26-8 is a deuterated isotopologue of the α-2 adrenergic receptor agonist, lofexidine hydrochloride. This compound is of critical importance as a high-purity internal standard for the precise quantification of lofexidine in complex biological matrices using advanced analytical techniques. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in bioanalytical method development, pharmacokinetic studies, and clinical trial support.

Application

• Bioanalytical Internal Standard: Serves as a critical reference material for the accurate quantification of lofexidine in plasma, serum, and urine via LC-MS/MS and GC-MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion in preclinical and clinical research.
• Metabolite Identification and Profiling: Used as a stable isotope-labeled tracer to distinguish drug-derived metabolites from endogenous compounds.
• Method Development and Validation: Essential for developing and validating robust, regulatory-compliant analytical methods for drug substance and product testing.
• Forensic and Clinical Toxicology: Supports accurate analysis in forensic investigations and therapeutic drug monitoring programs.
• Pharmaceutical Quality Control: Can be utilized in impurity profiling and stability-indicating assays for lofexidine-containing drug products.

Basic Information

Product Name	Lofexidine-D4 Hydrochloride
CAS No.	78302-26-8
Molecular Formula	C11H8D4Cl2N2O • HCl
Molecular Weight	285.61 g/mol (for monoisotopic mass)
Synonyms	2-[1-(2,6-Dichlorophenoxy)ethyl]-4,5-dihydro-1H-imidazole-d4 Hydrochloride; Lofexidine-d4 HCl; Lofexidine (phenyl-d4) Hydrochloride; BritLofex-d4 Hydrochloride; (RS)-Lofexidine-d4 Hydrochloride; Lofetensin-d4; Ba-168-d4 Hydrochloride
EINECS	Contact for details

Quality Control

Our Lofexidine-D4 Hydrochloride is manufactured under controlled conditions to ensure the highest standards of isotopic purity and chemical integrity. Each batch is subjected to rigorous analytical testing, including NMR (¹H, ¹³C) for isotopic enrichment verification and HPLC for chemical purity assessment. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, assay, isotopic purity, and related substances. Our quality system supports compliance with cGMP standards for use in regulated bioanalytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium, D)	≥ 98 atom % D
Isotopic Enrichment (by MS)	≥ 95% D4 (M+4)
Chemical Purity (by NMR)	≥ 97%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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