Description

Demethyl Benzydamine-D3 Hydrochloride is a deuterium-labeled isotopologue of a key benzydamine derivative, serving as a critical internal standard for precise quantitative analysis in bioanalytical and pharmacokinetic studies. Its high isotopic purity and chemical stability are essential for ensuring the accuracy and reliability of mass spectrometry-based assays. This compound is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug metabolism and development.

Application

• Internal Standard for LC-MS/MS: Used as a quantitative reference standard in the bioanalysis of benzydamine and its metabolites in biological matrices like plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Metabolism Research: Facilitates the identification and quantification of metabolic pathways and degradation products.
• Method Development and Validation: Critical for establishing and validating robust, sensitive, and specific analytical methods in compliance with GLP and FDA/EMA guidelines.
• Quality Control in Reference Material Production: Employed in the calibration and quality assurance of certified reference materials (CRMs).

Basic Information

Product Name	Demethyl Benzydamine-D3 Hydrochloride
CAS No.	1246817-08-2
Molecular Formula	C19H20D3ClN2O • HCl
Molecular Weight	369.33 g/mol (approx.)
Synonyms	Benzydamine-d3 N-Oxide Hydrochloride; 1-Benzyl-3-(3-(dimethylamino-d3)propoxy)-1H-indazole Hydrochloride; Deuterated Benzydamine N-Oxide HCl; 1H-Indazole, 1-benzyl-3-[3-(dimethylamino-d3)propoxy]-, hydrochloride, N-oxide; Benzydamine D3 Metabolite Standard
EINECS	Contact for details

Quality Control

Our Demethyl Benzydamine-D3 Hydrochloride is manufactured under strict quality systems to ensure high chemical and isotopic purity suitable for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay, isotopic enrichment, and impurity profile. We adhere to relevant industry standards for reference materials to support your compliance with GLP, FDA, and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 99.0 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.