Description

Ambroxol Imp.O CAS NO 1807328-39-7 is a high-purity reference standard and pharmaceutical intermediate, specifically identified as a key impurity or related substance of the active pharmaceutical ingredient Ambroxol. This compound is critical for ensuring the quality, safety, and efficacy of Ambroxol-based pharmaceutical formulations through rigorous analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and regulatory compliance for respiratory medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ambroxol Impurity O in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing of Ambroxol API batches to ensure impurity profiles meet pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings with agencies like the FDA and EMA.
• Research & Development: Serves as a critical intermediate or marker in the synthesis and process optimization of Ambroxol and its derivatives.

Basic Information

Product Name	Ambroxol Imp.O
CAS No.	1807328-39-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ambroxol Related Compound O; Ambroxol Impurity O; Ambroxol EP Impurity O; Ambroxol USP Impurity O; trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol (likely structure); Ambroxol Degradation Product; Ambroxol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Imp.O is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, 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 results for identity, purity, and impurities. Our quality commitment aligns with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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.