Description

1'-Hydroxymidazolam-13C3 is a stable isotope-labeled analog of the primary metabolite of the sedative-hypnotic drug midazolam. This compound is of critical importance for quantitative bioanalytical applications, providing an essential internal standard for mass spectrometry to ensure accurate and precise pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and forensic toxicology units engaged in advanced drug metabolism and pharmacokinetics (DMPK) research.

Application

• Primary use as an isotopic internal standard in LC-MS/MS and GC-MS bioanalysis for quantifying 1'-hydroxymidazolam in biological matrices.
• Critical for pharmacokinetic (PK) studies and drug metabolism research involving midazolam, a CYP3A4 probe substrate.
• Enables high-accuracy therapeutic drug monitoring (TDM) in clinical settings for patients undergoing midazolam therapy.
• Supports forensic and clinical toxicology investigations to determine midazolam exposure and metabolism.
• Facilitates drug-drug interaction studies by providing a reliable reference for measuring metabolic pathway alterations.
• Essential in the development and validation of regulatory-compliant bioanalytical methods (following FDA/EMA guidelines).

Basic Information

Product Name	1'-Hydroxymidazolam-13C3
CAS No.	1189677-14-2
Molecular Formula	C18H10ClFN5O (with three 13C atoms)
Molecular Weight	~340.75 g/mol (exact mass varies with isotopic enrichment)
Synonyms	1'-Hydroxymidazolam-13C3; 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-1,2,4-triazolo[4,3-a][1,4]benzodiazepine-1'-ol-13C3; 1'-OH-Midazolam-13C3; Labeled 1'-Hydroxymidazolam; Midazolam Metabolite-13C3; [13C3]-1'-Hydroxymidazolam; 1'-Hydroxy Midazolam (13C Labeled); Stable Isotope Labeled 1'-Hydroxymidazolam
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured under strict quality control protocols to ensure isotopic and chemical purity for demanding analytical applications. Each batch is characterized using advanced techniques including NMR, HPLC, and high-resolution mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing isotopic enrichment (typically ≥99% 13C atom percent), chemical purity, and analytical results. Our quality system supports compliance with GMP/GLP principles for research use.

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); keep the container tightly sealed in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (13C NMR/MS)	≥99% atom 13C (at labeled positions)
Chemical Purity	≥95.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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