Description

4-Hydroxymidazolam is a key pharmacologically active metabolite of the sedative-hypnotic agent Midazolam. This compound is of significant importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the development of analytical reference standards. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in bioequivalence studies, forensic toxicology, and the development of new therapeutic formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Midazolam and its metabolites in biological matrices.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic pathways, clearance, and activity profile of Midazolam.
• Analytical Method Development: Used to develop, validate, and calibrate high-performance liquid chromatography (HPLC), LC-MS/MS, and other analytical methods in clinical and forensic labs.
• Bioequivalence & Pharmacokinetic Studies: Essential for measuring the concentration of the active metabolite in plasma to assess drug performance and safety.
• Forensic Toxicology: Employed as an analytical standard for the accurate identification and quantification of Midazolam exposure in forensic investigations.
• Impurity Profiling: Used in the quality control of Midazolam active pharmaceutical ingredient (API) to monitor and control related substance levels.

Basic Information

Product Name	4-Hydroxymidazolam
CAS No.	59468-85-8
Molecular Formula	C18H13ClFN3O
Molecular Weight	341.77 g/mol
Synonyms	1H-Imidazol-1-ethanol, α-methyl-6-(2-fluorophenyl)-4-hydroxy-α-phenyl-, α-4-Dihydroxymidazolam; 4'-Hydroxymidazolam; α-Hydroxymidazolam; Midazolam Metabolite; 4-OH-Midazolam; U-44900; Ro 21-9098 metabolite
EINECS	Contact for details

Quality Control

Our 4-Hydroxymidazolam is produced and tested under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets high-purity standards suitable for research and analytical applications. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
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.