Description

Ambroxol Impurity 8 (Ambroxol Impurity M) is a high-purity 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 HCl. It is an essential tool for researchers, analytical chemists, and quality assurance professionals in the pharmaceutical industry who require precise identification, quantification, and control of related substances.

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material (CRM) for the identification and quantification of Ambroxol Impurity M in Ambroxol HCl API and finished dosage forms.
• Method Development & Validation: Used in developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for specified impurities.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Ambroxol manufacturing process to minimize impurity formation.

Basic Information

Product Name	Ambroxol Impurity 8 (Ambroxol Impurity M)
CAS No.	1445719-53-8
Molecular Formula	C13H18Br2N2O
Molecular Weight	378.10 g/mol
Synonyms	trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol; Ambroxol Impurity M; Ambroxol Related Compound M; Ambroxol EP Impurity M; Ambroxol USP Impurity M; Ambroxol Hydrochloride Impurity M; Ambroxol Metabolite; Ambroxol Degradation Product
EINECS	Contact for details

Quality Control

Our Ambroxol Impurity 8 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and confirmed by advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

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 at 2-8°C. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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