Description

Midazolam-D6 (1.0 mg/mL in Acetonitrile) is a deuterium-labeled internal standard of the sedative-hypnotic drug Midazolam, essential for ensuring accuracy and precision in quantitative bioanalytical methods. This certified reference material is specifically formulated for use in Liquid Chromatography-Mass Spectrometry (LC-MS) applications, providing a critical tool for method validation and regulatory compliance. It is primarily used by analytical laboratories and pharmaceutical companies engaged in pharmacokinetic studies, therapeutic drug monitoring, and forensic toxicology.

Application

• Quantitative LC-MS/MS Analysis: Serves as a stable isotope-labeled internal standard for the precise quantification of Midazolam and its metabolites in complex biological matrices such as plasma, serum, and urine.
• Pharmacokinetic and Bioequivalence Studies: Enables accurate measurement of drug concentration-time profiles, critical for drug development and regulatory submissions.
• Therapeutic Drug Monitoring (TDM): Used in clinical laboratories to monitor Midazolam levels in patients, aiding in dose optimization and safety.
• Forensic and Clinical Toxicology: Facilitates the reliable identification and quantification of Midazolam in post-mortem and impairment casework.
• Method Development and Validation: Provides a key component for developing robust, selective, and sensitive analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Metabolism and Disposition Research: Supports studies investigating the metabolic pathways and clearance of Midazolam.

Basic Information

Product Name	Midazolam-D6 (1.0 mg/mL in Acetonitrile)
CAS No.	1246819-79-3
Molecular Formula	C₁₈H₁₀D₆ClFN₃
Molecular Weight	331.81 g/mol (approximate)
Synonyms	8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine-d6; Midazolam-d6; Deuterated Midazolam; Midazolam Internal Standard; Midazolam (hexadeuterated); Midazolam-d6 solution; Midazolam D6; 1.0 mg/mL Midazolam-d6 in Acetonitrile
EINECS	Contact for details

Quality Control

Every batch of Midazolam-D6 solution is manufactured and certified to the highest standards for use as a certified reference material. Our products undergo rigorous quality testing, including identity confirmation by mass spectrometry and quantitative assay by HPLC, to ensure compliance with industry standards. Certificates of Analysis (COA) are provided with each shipment, detailing the exact concentration, isotopic purity, and solvent verification.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. The solution is highly volatile due to the acetonitrile solvent; ensure proper ventilation and handle in a well-ventilated area or fume hood. For long-term stability, keep the vial upright and minimize freeze-thaw cycles.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow solution
Concentration	1.0 mg/mL (as free base)
Solvent	Acetonitrile
Identification (MS)	Conforms to structure
Assay (HPLC)	98.0% - 102.0% of stated concentration
Isotopic Purity	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 99.0%

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