Ambroxol Impurity 1

Development and validation of a stability-indicating LC method for simultaneous determination of related compounds of guaifenesin, terbutaline sulfate and ambroxol HCl in cough syrup formulation
K. Lakshmi Narasimha Rao a,b, Ch. Krishnaiah a , K. Sudheer Babu a , K. Padmaja Reddy
Journal of Saudi Chemical Society 18(5):593-600
 
Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques
Veera Raghava Raju Thummala , Mrutyunjaya Rao Ivaturi , Someswara Rao Nittala
Sci Pharm. 2014; 82: 247–263
 
Development and Validation of RP-HPLC Method for Simultaneous Determination of Guaifenesin Impurities in Multi Drug Combinations
By Levon A. Melikyan, Rosa S. Grigoryan & Tigran K. Davtyan
Global Journal of Medical research: B Pharma, Drug Discovery, Toxicology and Medicine Volume 14 Issue 2 Version 1.0 Year 2014

Ambroxol Impurity 1 is chemically Trans-4-[(2-Amino-5-bromobenzyl)amino]cyclohexanol hydrochloride. It is also known as Ambroxol Monobromo Impurity. Ambroxol Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Ambroxol Impurity 1 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Ambroxol .

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.