Amiodarone EP Impurity H

Quality by design (QbD) based development and validation of an HPLC method for amiodarone hydrochloride and its impurities in the drug substance
S. Karmarkar ∗, X. Yang, R. Garber, A. Szajkovics, M. Koberda
Journal of Pharmaceutical and Biomedical Analysis 100 (2014) 167–174
 
Validation of a Stability-Indicating HPLC Method for the Determination of Amiodarone HCl and Its Related Substances in Amiodarone HCl Injection
Matthew J. Christopherson,* Kenton J. Yoder, and R. Brent Miller
Journal of liquid chromatography & related technologies vol. 27, No. 1, pp. 95–111, 2004
 
Stability-indicating HPLC method for determination of amiodarone hydrochloride and its impurities in tablets: a detailed forced degradation study
Ana Silva Coelho1 , Igor Felipe Rodrigues Ribeiro1 , Eduardo Burgarelli Lages
Braz. J. Pharm. Sci. vol.56
 
Validation of a Stability Indicating LC Method for Amiodarone HCL and Related Substances
M. A. Khan, S. Kumar, J. Jayachandran, S. V. Vartak, A. Bhartiya, S. Sinha
Chromatographia volume 61, pages599–607(2005)

Amiodarone EP Impurity H is chemically 2-chloro-N,N-diethylethanamine (as per EP) ; 2-chloro-N,N-diethylethanamine hydrochloride (as per USP). It is also known as Amoidarone USP Related Compound H ; (2-Chloroethyl)diethylamine Hydrochloride. Amiodarone EP Impurity H is supplied with detailed characterization data compliant with regulatory guideline. Amiodarone EP Impurity H 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 Amiodarone.

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.