Description

Ambroxol Cycloimine Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Ambroxol Hydrochloride. This high-purity compound is essential for ensuring the safety and efficacy of finished drug products by enabling the accurate identification, quantification, and control of process-related impurities. It is primarily utilized by analytical chemists, quality assurance professionals, and research scientists within the pharmaceutical industry for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the identification and quantification of the cycloimine impurity in Ambroxol Hydrochloride API and its formulations.
• Analytical Method Development and Validation (HPLC/GC): Used as a critical standard to develop, optimize, and validate chromatographic methods for impurity analysis.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Ambroxol batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies and Forced Degradation Studies: Employed to monitor impurity levels over time and to understand the degradation pathways of the Ambroxol API.
• Regulatory Submissions and Compliance: Provides necessary 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: Used in synthetic chemistry research to study the formation and mitigation of this specific impurity during the API manufacturing process.

Basic Information

Product Name	Ambroxol Cycloimine Impurity
CAS No.	73220-00-5
Molecular Formula	C13H16Br2N2O
Molecular Weight	376.09 g/mol
Synonyms	trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol; Ambroxol Impurity C; Ambroxol EP Impurity C; Ambroxol Related Compound C; Ambroxol Cycloimine; 2-Amino-3,5-dibromo-N-[(1R,4R)-4-hydroxycyclohexyl]benzylamine; UNII-6J1V7F8U4I
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Cycloimine Impurity CAS 73220-00-5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 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.