Description

Ambroxol Ep Impurity D-D5 is a high-purity, deuterated reference standard specifically designed for advanced analytical applications. This compound is critical for ensuring the accuracy and reliability of pharmaceutical quality control processes, particularly in the development and validation of analytical methods for the active pharmaceutical ingredient Ambroxol. It serves as an essential tool for researchers and quality assurance professionals in the pharmaceutical industry who require precise impurity profiling and method development to meet stringent regulatory standards.

Application

• Primary use as a deuterated internal standard for the precise quantification of Ambroxol and its related impurities via LC-MS and GC-MS.
• Critical component in pharmaceutical analytical method development and validation for Ambroxol-based drug products.
• Used for impurity identification and characterization studies to support regulatory filings (e.g., ANDA, NDA).
• Essential reference material in stability studies to track degradation pathways and ensure product shelf-life.
• Supports quality control and assurance laboratories in maintaining compliance with pharmacopeial standards (USP, EP).
• Valuable for metabolite studies and pharmacokinetic research involving deuterium labeling.

Basic Information

Product Name	Ambroxol Ep Impurity D-D5
CAS No.	1217679-83-8
Molecular Formula	C13H13D5Br2N2O
Molecular Weight	393.09 g/mol
Synonyms	trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol-d5; Ambroxol Impurity D (deuterated); Ambroxol Related Compound D-D5; Deuterated Ambroxol EP Impurity D; 4-[[(2-Amino-3,5-dibromophenyl)methyl]amino]cyclohexanol-d5; Ambroxol-d5 Impurity; (1r,4r)-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol-d5
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Ep Impurity D-D5 is manufactured and tested under strict quality management systems. The product undergoes rigorous analytical characterization using techniques such as NMR (1H, 13C), Mass Spectrometry, and HPLC to confirm identity, isotopic purity (D-content), and chemical purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards are designed to support compliance with ICH Q3A/B, USP, and EP guidelines for impurities and reference standards.

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 (e.g., nitrogen atmosphere) after opening to maintain stability and purity. Keep the container tightly sealed in a desiccator for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Single Maximum Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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