Description

Loprazolam-D8 is a deuterated analog of the benzodiazepine loprazolam, specifically labeled with eight deuterium atoms at key positions to enhance metabolic stability and isotopic fidelity. It serves as a critical internal standard in quantitative bioanalysis—enabling highly accurate and reproducible measurement of loprazolam in biological matrices via LC-MS/MS. This compound is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bioequivalence studies requiring rigorous pharmacokinetic validation.

Application

• Internal standard for LC-MS/MS quantification of loprazolam in plasma, serum, and urine
• Reference material in bioanalytical method validation (selectivity, accuracy, precision, matrix effect)
• Calibration standard in preclinical and clinical pharmacokinetic (PK) studies
• Quality control benchmark for stability-indicating assays during drug metabolism investigations
• Tool compound in isotope-dilution mass spectrometry (IDMS) workflows for regulatory submissions (FDA, EMA)
• Supporting material for GCP-compliant bioequivalence and first-in-human (FIH) trial analytics

Basic Information

Product Name	Loprazolam-D8
CAS No.	1346606-41-4
Molecular Formula	C15D8ClN3O2
Molecular Weight	329.75 g/mol
Synonyms	Loprazolam-d8; 6-(2-Chlorophenyl)-1-(2,2-dideuterioethyl)-8-fluoro-4-methyl-2,5-diazabicyclo[2.2.2]oct-2-ene-3-one-d8; Loprazolam-2,2,4,4,6,6,8,8-d8; [D8]-Loprazolam; Deuterated Loprazolam; 1346606-41-4; Loprazolam-d8 (8D, 98%); 6-(2-Chlorophenyl)-8-fluoro-1-(2,2-dideuterioethyl)-4-methyl-2,5-diazabicyclo[2.2.2]oct-2-ene-3-one-d8
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is verified for isotopic enrichment (≥98% D-incorporation), chemical purity (≥98.5% by HPLC), identity (IR and 1H/2H NMR), and absence of residual solvents per ICH Q3C guidelines. Testing adheres to ISO/IEC 17025-accredited practices and supports GMP-aligned documentation requirements for regulated bioanalytical use.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8 °C under inert atmosphere (argon or nitrogen) to prevent degradation. Due to its hygroscopic nature, minimize exposure to ambient humidity; allow container to equilibrate to room temperature before opening to avoid condensation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches certified reference standard
Assay (HPLC)	≥98.5%
Isotopic Purity (Mass Spec)	≥98% deuterium incorporation at designated positions
Residual Solvents (GC)	Meets ICH Q3C limits
Water Content (Karl Fischer)	≤0.5%
Heavy Metals	≤10 ppm

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