Description

Ambroxol Ep Impurity B-D5 Dihydrochloride is a deuterated, high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing ambroxol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ambroxol Ep Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive and specific chromatographic methods, such as HPLC and LC-MS/MS, for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against established pharmacopeial limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of specified impurities in ambroxol formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Deuterated Internal Standard: The deuterated (D5) form is ideal for use as an internal standard in mass spectrometry-based assays, improving accuracy and precision by correcting for matrix effects and instrument variability.

Basic Information

Product Name	Ambroxol Ep Impurity B-D5 Dihydrochloride
CAS No.	1794752-24-1
Molecular Formula	C13H13D5Br2N2O•2HCl
Molecular Weight	Contact for details
Synonyms	trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol-d5 Dihydrochloride; Ambroxol Impurity B D5 Dihydrochloride; Ambroxol EP Impurity B (D5) Dihydrochloride; Ambroxol Related Compound B D5 Dihydrochloride; Deuterated Ambroxol Impurity B Dihydrochloride; [D5]-Ambroxol Impurity B 2HCl; (1r,4r)-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol-d5 Dihydrochloride
EINECS	Contact for details

Quality Control

Our Ambroxol Ep Impurity B-D5 Dihydrochloride is manufactured under strict quality control protocols to ensure it meets the exacting standards for pharmaceutical reference materials. Each batch is characterized and tested using advanced analytical techniques, including NMR, HPLC, and MS, to confirm identity, chemical purity, and isotopic enrichment. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Isotopic Purity (D5)	≥ 98.0 atom % D
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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