Description

Phentolamine-D4 Hydrochloride is a high-purity, deuterium-labeled internal standard critical for ensuring analytical accuracy in quantitative bioanalysis. This stable isotope-labeled compound is essential for researchers and quality control laboratories requiring precise and reliable measurement of Phentolamine and its metabolites. It is primarily utilized in pharmaceutical research, clinical diagnostics, and forensic toxicology for method development and validation using advanced techniques like LC-MS/MS.

Application

• Quantitative Bioanalysis: Serves as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the accurate quantification of Phentolamine in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion in preclinical and clinical research.
• Metabolite Profiling: Used in metabolism studies to identify and quantify the metabolic pathways of Phentolamine.
• Forensic and Clinical Toxicology: Supports accurate assay development for detecting and measuring Phentolamine in forensic investigations and overdose cases.
• Pharmaceutical Quality Control: Ensures batch-to-batch consistency and purity verification of active pharmaceutical ingredients (APIs) and finished drug products.
• Regulatory Submissions: Provides the validated data required for regulatory compliance in new drug applications (NDA) and investigational new drug (IND) filings to agencies like the FDA and EMA.

Basic Information

Product Name	Phentolamine-D4 Hydrochloride
CAS No.	1346599-65-2
Molecular Formula	C17H15D4N3O • HCl
Molecular Weight	317.82 g/mol (approx.)
Synonyms	2-[[N-(3-Hydroxyphenyl)-4,5-dihydro-1H-imidazol-2-yl]methyl-d4amino]phenol hydrochloride; Phentolamine-d4 HCl; Deuterated Phentolamine Hydrochloride; Phentolamine (phenyl-d4) Hydrochloride; Regitine-d4 Hydrochloride; 3-[[(4,5-Dihydro-1H-imidazol-2-yl)methyl-d4](4-hydroxyphenyl)amino]phenol hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Phentolamine-D4 Hydrochloride is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure identity, purity, and isotopic enrichment meet the highest standards. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes data for critical parameters such as assay by HPLC, isotopic purity (D-enrichment), and related substances. Our quality commitment supports compliance with cGMP and ICH guidelines for pharmaceutical reference standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Assay (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98.0 atom % D
Chemical Purity (HPLC)	≥99.0%
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.