Description

Ambroxol Impurity 42 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Ambroxol hydrochloride. It is an essential tool for researchers and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories who require reliable impurity standards for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor Ambroxol Impurity 42 during API synthesis and formulation.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to ensure accurate impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to confirm that Ambroxol API and finished drug products meet stringent pharmacopeial (e.g., USP, EP, JP) impurity limits.
• Stability Studies and Forced Degradation: Used to assess the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Research and Development: Facilitates process chemistry optimization by helping scientists understand and minimize the formation of this impurity during Ambroxol synthesis.

Basic Information

Product Name	Ambroxol Impurity 42
CAS No.	53874-71-8
Molecular Formula	C13H18Br2N2O
Molecular Weight	378.10 g/mol
Synonyms	trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol; Ambroxol Related Compound B; Ambroxol EP Impurity B; Ambroxol USP Related Compound B; Ambroxol Impurity B; 4-[[(2-Amino-3,5-dibromophenyl)methyl]amino]cyclohexanol (trans-isomer); Ambroxol Metabolite II (referenced in some literature); ABX Impurity 42
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Impurity 42 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting regulatory compliance for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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