Description

Ambroxol Hydrochloride Impurity B is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Ambroxol Hydrochloride. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes. The material is supplied with comprehensive analytical data to support compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ambroxol Hydrochloride Impurity B in drug substances and finished products.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing, optimizing, and validating chromatographic methods to monitor impurities in Ambroxol Hydrochloride API.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug purity meets pharmacopeial (e.g., USP, EP, BP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing necessary impurity characterization data.
• Research & Development (R&D): Facilitates impurity profiling and route scouting during the synthesis and process development of Ambroxol Hydrochloride.

Basic Information

Product Name	Ambroxol Hydrochloride Impurity B
CAS No.	15942-08-2
Molecular Formula	C13H18Br2N2O • HCl
Molecular Weight	414.01 g/mol
Synonyms	trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride; Ambroxol Impurity B; Ambroxol Related Compound B; Ambroxol EP Impurity B; Ambroxol Hydrochloride EP Impurity B; Ambroxol HCl Impurity B; 4-[[(2-Amino-3,5-dibromophenyl)methyl]amino]cyclohexanol Hydrochloride (trans-); NA-872 Hydrochloride Impurity
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Hydrochloride Impurity B is manufactured and analyzed under strict quality management systems. The material is characterized using advanced analytical techniques including HPLC, GC, NMR, and MS to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be opened under dry, inert conditions when necessary.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.