Description

Ambroxol-D5 Hcl CAS NO 1246818-80-3 is a deuterated isotopologue of the established mucolytic agent ambroxol hydrochloride, where five hydrogen atoms are replaced with deuterium. This stable isotope-labeled compound is a critical reference standard and intermediate in modern pharmaceutical research and development. It is primarily utilized by analytical scientists and R&D departments in the pharmaceutical, contract research, and academic sectors for advanced studies.

Application

• Internal Standard for Quantitative Bioanalysis: Essential for Liquid Chromatography-Mass Spectrometry (LC-MS/MS) methods in pharmacokinetic and metabolism studies due to its nearly identical chemical properties with minimal isotopic interference.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Used as a tracer to investigate the absorption, distribution, metabolism, and excretion (ADME) profiles of ambroxol.
• Pharmaceutical Impurity Profiling: Serves as a critical marker in the development and validation of analytical methods to identify and quantify process-related substances.
• Clinical Research & Biomarker Studies: Employed in the accurate quantification of ambroxol levels in biological matrices during clinical trials.
• Synthesis of Deuterated Drug Candidates: Acts as a key building block or precursor for the synthesis of more complex deuterated molecules being explored for improved metabolic stability.
• Quality Control & Method Development: Integral to establishing and maintaining rigorous quality control protocols in analytical laboratories for ambroxol-based pharmaceuticals.

Basic Information

Product Name	Ambroxol-D5 Hydrochloride
CAS No.	1246818-80-3
Molecular Formula	C13H13D5Br2N2O • HCl
Molecular Weight	414.57 g/mol
Synonyms	trans-4-[(2-Amino-3,5-dibromobenzyl)amino]-cyclohexanol-D5 hydrochloride; Ambroxol-d5 HCl; Deuterated Ambroxol Hydrochloride; 2-Amino-3,5-dibromo-N-[(1R,4R)-4-(hydroxy-D)-cyclohexyl-D4]benzylamine hydrochloride; Ambroxol (pentadeutero) hydrochloride; (1R,4R)-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol-d5 hydrochloride
EINECS	Contact for details

Quality Control

Our Ambroxol-D5 HCl is manufactured under strict quality systems to ensure high chemical and isotopic purity, essential for reliable analytical results. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and Mass Spectrometry, to confirm structure, isotopic enrichment, and purity. A comprehensive Certificate of Analysis (COA) detailing assay, chemical purity, isotopic purity (D-enrichment), and residual solvent analysis is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions after opening to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 99.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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