Description

4-Desfluoro-4-[4-(2-Oxo-2,3-Dihydro-1H-Benzimidazol-1-Yl)-3,6-Dihydropyridin-1(2H)-Yl] Droperidol-D4 is a high-purity, deuterium-labeled analog of a droperidol derivative, specifically designed for use as a critical reference standard in analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative analysis, particularly in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities that require precise internal standards for mass spectrometry (LC-MS/MS).

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the quantitative bioanalysis of droperidol and its metabolites in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) studies using stable isotope dilution methods.
• Clinical Research & Toxicology: Used in method development and validation for therapeutic drug monitoring (TDM) and forensic toxicology assays.
• Impurity Profiling: Aids in the identification and quantification of process-related impurities and degradants during drug substance manufacturing.
• Regulatory Submissions: Supports data packages for regulatory authorities (FDA, EMA) by providing traceable and consistent analytical results.

Basic Information

Product Name	4-Desfluoro-4-[4-(2-Oxo-2,3-Dihydro-1H-Benzimidazol-1-Yl)-3,6-Dihydropyridin-1(2H)-Yl] Droperidol-D4
CAS No.	1346604-49-6
Molecular Formula	C22H22D4N4O2
Molecular Weight	Contact for details
Synonyms	Droperidol D4 Derivative; 4-Desfluoro Droperidol D4; Droperidol-d4 (defluorinated analog); 1-[1-[4-(4-Fluorophenyl)-4-oxobutyl]-1,2,3,6-tetrahydro-4-pyridinyl]-2-benzimidazolinone-d4 (defluorinated); 4-[4-(2-Oxo-2,3-dihydro-1H-benzimidazol-1-yl)-3,6-dihydropyridin-1(2H)-yl]-1-[4-(fluorophenyl)butan-1-one]-d4 (defluorinated); Deuterated Droperidol Impurity Standard; Stable Isotope Labeled Internal Standard for Droperidol.
EINECS	Contact for details

Quality Control

Our deuterated reference standards are produced under strict quality control protocols to ensure isotopic purity, chemical purity, and stability. Each batch is characterized using advanced analytical techniques including NMR (¹H, ¹³C), high-resolution mass spectrometry (HRMS), and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing the isotopic enrichment (D-content), chemical purity, and results from all identification tests, ensuring full traceability and compliance with ICH Q2(R1) guidelines for analytical method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

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 (D-content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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