Description

Ambroxol Ep Impurity D is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Ambroxol Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments for method development, validation, and compliance with stringent pharmacopeial standards such as EP and USP.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ambroxol Ep Impurity D in Ambroxol Hydrochloride API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating assay methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure API and drug product batches meet specified impurity limits as per ICH guidelines.
• Stability Studies: Used to track the formation and level of this specific impurity over time under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Pharmacopeial Compliance: Supports compliance testing against monographs in the European Pharmacopoeia (EP) and other international pharmacopeias.

Basic Information

Product Name	Ambroxol Ep Impurity D
CAS No.	107814-37-9
Molecular Formula	C13H18Br2N2O
Molecular Weight	378.10 g/mol
Synonyms	trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol; Ambroxol Impurity D; Ambroxol Related Compound D; 4-[[(2-Amino-3,5-dibromophenyl)methyl]amino]cyclohexanol (trans-isomer); Ambroxol EP Impurity D; Ambroxol Hydrochloride Impurity D; Ambroxol Impurity 4; UNII-8W4N5P2M3T
EINECS	Contact for details

Quality Control

Our Ambroxol Ep Impurity D is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles as determined by validated methods (HPLC, NMR, MS). Quality systems are designed to support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

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