Description

Ambroxol Impurity 41 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Ambroxol. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Ambroxol-based drug products by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical laboratories, pharmaceutical manufacturers, and research institutions focused on respiratory therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ambroxol Impurity 41 in drug substances and products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Ambroxol.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of Ambroxol formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and process chemistry research to understand and minimize impurity formation.

Basic Information

Product Name	Ambroxol Impurity 41
CAS No.	861528-70-3
Molecular Formula	C19H24Br2N2O
Molecular Weight	456.22 g/mol
Synonyms	trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol; Ambroxol Related Compound A; Ambroxol EP Impurity A; Ambroxol USP Impurity; Ambroxol Process Impurity; Ambroxol Degradation Product; 2-Amino-3,5-dibromo-N-[(1R,2R)-2-hydroxycyclohexyl]benzylamine (trans isomer)
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Impurity 41 CAS NO 861528-70-3 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical results.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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