Description

Ambroxol Impurity 11 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 research institutions engaged in method development, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for accurate quantification and control of this specific impurity in the active pharmaceutical ingredient (API) and finished drug products.

Application

• Pharmaceutical Impurity Profiling and Identification as a certified reference material for HPLC, LC-MS, and GC-MS analysis.
• Method Development and Validation for analytical procedures in quality control (QC) laboratories.
• Stability Studies to monitor the formation and levels of this impurity in Ambroxol API and formulations over time.
• Regulatory Compliance and Documentation to meet ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.
• Research and Development for studying the degradation pathways and chemical behavior of Ambroxol.
• Calibration Standard for quantitative analysis to establish impurity limits and ensure batch-to-batch consistency.

Basic Information

Product Name	Ambroxol Impurity 11
CAS No.	2088879-81-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ambroxol Related Compound 11; Ambroxol EP Impurity J; Ambroxol Hydrochloride Impurity 11; Ambroxol Impurity J; trans-4-((6,8-Dibromoquinazolin-4-yl)amino)cyclohexanol (probable structure); Ambroxol Quinazoline Impurity
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Impurity 11 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with specified criteria and supporting regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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