Description

Rac-n-Demethyl Dimethindene-D3 Hydrobromide is a deuterated isotopologue of a key antihistamine metabolite, specifically designed for use as an internal standard in advanced analytical chemistry. This high-purity reference material is critical for ensuring the accuracy and reliability of quantitative analyses in complex matrices. It is primarily utilized by pharmaceutical research and development laboratories, contract research organizations (CROs), and analytical service providers engaged in method development, pharmacokinetic studies, and bioanalytical testing for CAS NO 1346604-45-2.

Application

• Internal Standard for LC-MS/MS: Essential for the precise quantification of dimethindene and its metabolites in biological samples (e.g., plasma, serum, urine) using mass spectrometry.
• Pharmaceutical R&D: Supports method development and validation for pharmacokinetic (PK) and pharmacodynamic (PD) studies of antihistamine drugs.
• Bioanalytical Testing: Used in CROs and quality control labs to ensure data integrity in clinical trial sample analysis.
• Metabolite Identification & Profiling: Aids in the study of drug metabolism pathways and the identification of specific demethylated metabolites.
• Forensic & Doping Control Analysis: Serves as a reference compound for the accurate detection and confirmation of antihistamine substances.
• Stability-Indicating Methods: Employed in the development of assays to monitor the stability and degradation of pharmaceutical formulations.

Basic Information

Product Name	Rac-n-Demethyl Dimethindene-D3 Hydrobromide
CAS No.	1346604-45-2
Molecular Formula	C20H21D3N2•HBr
Molecular Weight	Contact for details
Synonyms	Dimethindene D3 Metabolite; N-Desmethyl Dimethindene-D3 Hydrobromide; 2-[1-[1-(4-Methylphenyl)ethyl]-3-pyrrolidinyl]-1H-benzimidazole-d3 hydrobromide; Fenistil Metabolite D3 Standard; Deuteron-d3 Dimethindene N-Desmethyl Hydrobromide; (RS)-N-Desmethyl Dimethindene-D3 HBr; Deuterated Dimethindene Internal Standard
EINECS	Contact for details

Quality Control

Our Rac-n-Demethyl Dimethindene-D3 Hydrobromide is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), isotopic purity (D3 content), and identity confirmation. We support 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. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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