Ivabradine Dimer Impurity (HCl salt)

Ivabradine Dimer Impurity (HCl salt) is chemically (S)-3,3'-((((3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)azanediyl)bis(propane-3,1-diyl))bis(7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one) hydrochloride. It is also known as N-(Demethyl)diithabradine. Ivabradine Dimer Impurity (HCl salt) is supplied with detailed characterization data compliant with regulatory guideline. Ivabradine Dimer Impurity (HCl salt) 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 Ivabradine.

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.

Forced Degradation Studies of Ivabradine and In Silico Toxicology Predictions for Its New Designated Impurities
Piotr Pikul,1 Marzena Jamrógiewicz,1,* Joanna Nowakowska,1 Weronika Hewelt-Belka,2,3 and Krzesimir Ciura
Front Pharmacol. 2016; 7: 117.
 
Simultaneous determination of chiral and achiral impurities of ivabradine on a cellulose tris(3-chloro-4-methylphenylcarbamate) chiral column using polar organic mode
ElekFerenczabBélaKovácsabFranciscBodaaMohammadhassanForoughbakhshfasaeicÉva KatalinKelemenbGergőTóthcZoltán-IstvánSzabó
Journal of Pharmaceutical and Biomedical Analysis Volume 177, 5 January 2020, 112851
 
Characterization of degradation products of Ivabradine by LC-HR-MS/MS: a typical case of exhibition of different degradation behaviour in HCl and H2SO4 acid hydrolysis
Prinesh N. Patel,a Roshan M. Borkar,b Pradipbhai D. Kalariya,a Rahul P. Gangwal,c Abhay T. Sangamwar,c Gananadhamu Samanthulaa and Srinivas Ragampeta
J. Mass Spectrom. 2015, 50, 344–353
 
Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress Degradation
Joanna Nowakowska,1 Piotr Pikul,1,2 Marcin Marszałł,3 and Krzesimir Ciura
Hindawi Journal of Chemistry Volume 2017, Article ID 2069571, 7 pages
 
Quantitative Determination and Validation of Ivabradine HCL by Stability Indicating RP-HPLC Method and Spectrophotometric Method in Solid Dosage Form
Shweta Maheshwari 1  ,   Amit P. Khandhar 2,   Anurekha Jain
Eurasian J Anal Chem 2010;5(1):53–62

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