Description

Ambroxol Impurity 9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Ambroxol hydrochloride, a widely used mucolytic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The reliable identification and quantification of this impurity are essential for maintaining the stringent purity standards of the final active pharmaceutical ingredient (API).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ambroxol Impurity 9 in Ambroxol hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Ambroxol.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to demonstrate control over the manufacturing process.
• Research & Development: Utilized in synthetic chemistry research to study the formation, isolation, and characterization of process-related impurities.

Basic Information

Product Name	Ambroxol Impurity 9
CAS No.	2250242-11-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ambroxol Related Compound 9; Ambroxol EP Impurity 9; Ambroxol USP Impurity 9; Ambroxol Hydrochloride Impurity 9; trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol (presumed); Ambroxol Impurity C (if applicable); Ambroxol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Impurity 9 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from multiple orthogonal techniques such as HPLC, NMR, and MS to confirm identity and purity. We ensure compliance with relevant guidelines, including ICH Q3A/B for impurities and general pharmacopeial requirements. Certificates of Analysis (COA) are available upon request.

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 must be kept under inert conditions or in a desiccator after opening to prevent degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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