Dronedarone Hydrochloride Related Compounds & Impurities

Dronedarone Hydrochloride is a multichannel-blocking antiarrhythmic structurally related to amiodarone but without iodine, used for atrial fibrillation rhythm control.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Dronedarone Hydrochloride reference standards, pharmacopeial and non-pharmacopeial Dronedarone Hydrochloride impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Dronedarone Hydrochloride-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Dronedarone Hydrochloride
Dronedarone Imp-A (Des-(MethylSulphonyl)Impurity
Dronedarone EP Impurity C
Dronedarone Imp-C (Chloro Impurity)
Desbutyl Dronedarone Hydrochloride
Dronedarone N-Oxide
Dronedarone imp-F
Dronedarone imp 1
Dronedarone imp 2
Dronedarone intermediate-1 (4-Methoxybenzoyl Chloride)
Dronedarone intermediate-2 ( 3- dibutylamino propan-1-ol )
Benzbromarone Impurity 4
Dronedarone Impurity 14
Dronedarone intermediate-5 (6-Ethylpyrimidin-4-ol)
Dronedarone intermediate-6( 2 Butyl-5-nitrobenzofuran)
Dronedarone Impurity (N-(3-chloropropyl)butan-1-amine hydrochloride)
2-Hydroxy-5-nitrobenzaldehyde
Dronedarone Olefinic Impurity
Dronedarone Dimer Impurity
Dronedarone EP Impurity B
Dronedarone Impurity 11
4-(2-butyl-5-(methylsulfonamido)benzofuran-3-carbonyl)phenyl methanesulfonate
2-Hydroxy-5-nitrobenzyl bromide
2-Butyl-3-(4-hydroxybenzoyl)-5-nitrobenzofuran
Dronedarone Related Compound D
Dibutylamine
Dronedarone Impurity B Dihydrochloride
Dronedarone Related Compound C
N,N,N,N-Tetrabutylpropane-1,3-diamine
S-Desmethyl S-Chloromethyl Dronedarone
Dronedarone Hydroxy Impurity
Dronedarone EP Impurity A
((methylenebis(oxy))bis(4,1-phenylene))bis((2-butyl-5-nitrobenzofuran-3-yl)methanone)
Dronedarone KSM Impurity
Triphenyl-[2-hydroxy-5-nitrobenzyl]Phosphonium Bromide
N-Nitroso Dronedarone EP Impurity A
Dronedarone Impurity 13
Dronedarone Hydroxy Methyl Impurity
Dronedarone Impurity 2
Dronedarone Impurity 4
Dronedarone
Dronedarone Impurity 5

Isotope Labelled Compounds

Dronedarone-D6 Hydrochloride
Desbutyl Dronedarone-D4 Hydrochloride
Desbutyl Dronedarone-d6 Hydrochloride
Desbutyl Dronedarone-d7 HCl