Description

Midazolam n-β-D-Glucuronide is a high-purity reference standard and metabolite of the sedative-hypnotic drug Midazolam. This compound is essential for pharmaceutical research, development, and quality control, providing a critical benchmark for analytical studies. It is primarily used by researchers and quality assurance professionals in the pharmaceutical, forensic, and clinical toxicology sectors for method validation, pharmacokinetic studies, and metabolite identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative and qualitative analysis of Midazolam and its metabolites in drug formulations and biological matrices.
• Metabolite Research: Used in in vitro and in vivo studies to investigate the metabolic pathways, pharmacokinetics, and pharmacodynamics of Midazolam.
• Bioanalytical Method Development: Critical for developing and validating sensitive HPLC, LC-MS, and GC-MS methods for therapeutic drug monitoring and forensic analysis.
• Clinical Toxicology: Employed as a calibrator or control in assays to detect and quantify Midazolam exposure in clinical and forensic settings.
• Impurity Profiling: Used to identify and quantify glucuronidated metabolite impurities in active pharmaceutical ingredient (API) batches.
• Regulatory Compliance: Supports compliance testing for drug manufacturers, aligning with ICH, FDA, and EMA guidelines for impurity identification.

Basic Information

Product Name	Midazolam n-β-D-Glucuronide
CAS No.	1033824-50-8
Molecular Formula	C30H34ClN3O7
Molecular Weight	584.06 g/mol
Synonyms	Midazolam Glucuronide; Midazolam N-Glucuronide; 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid β-D-glucopyranosiduronic acid; 1-Methyl-8-chloro-6-(2-fluorophenyl)-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate β-D-glucuronide; Midazolam Metabolite (Glucuronide); Midazolam β-D-Glucuronide; Midazolam N-β-D-Glucopyranosiduronic Acid
EINECS	Contact for details

Quality Control

Every batch of Midazolam n-β-D-Glucuronide is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), identification (by NMR and MS), and impurity profile is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, keep desiccated under an inert atmosphere. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits
Specific Rotation	Contact for details

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