Description

Ambroxol Impurity 53 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Ambroxol, a widely used mucolytic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Ambroxol HCl drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Essential for forced degradation and long-term stability studies to identify and track degradation products of Ambroxol.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive understanding and control of the drug substance.
• Research & Development: Used in academic and industrial R&D for studying the metabolism, degradation pathways, and synthesis of Ambroxol-related compounds.

Basic Information

Product Name	Ambroxol Impurity 53
CAS No.	2499966-00-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ambroxol Related Compound 53; Ambroxol EP Impurity I; Ambroxol USP Impurity; trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol Impurity; Ambroxol Degradation Product; Ambroxol Process Impurity; Ambroxol Metabolite; ABX Impurity 53
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Impurity 53 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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