Nicardipine EP Impurity A (Oxalate salt)

Stability-indicating HPLC method for the determination of nicardipine in capsules and spiked human plasma. Identification of degradation products using HPLC/MS
Sheikha M.Al-Ghannam,Abeer M.Al-Olayan
Arabian Journal of Chemistry Volume 12, Issue 8, December 2019, Pages 1983-1993
 
Employing ionization behaviors to resolve a trace-level impurity: determination of 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5- pyridinedicarboxylic acid di-2-[methyl-(phenylmethyl)amino]ethyl ester in nicardipine drug substance
M B Maurin 1, R D Vickery, P Ma, J Manalo, M A Hussain
Pharm Res. 1992 Nov;9(11):1518-20.
 
Chromatographic purity and assay of nicardipine by HPLC
C. V. Fernández  D. F. Mira  G. I. Luque
Journal of High Resolution Chromatography Volume13, Issue12 December 1990 Pages 846-849
 
Identification and characterization of a novel potential degradant and development and validation of stability-indicating rp-lc method for nicardipine impurities in injectable dosage form
Bhupendrasinh K. Vaghela  &Surendra Singh Rao
Journal of Liquid Chromatography & Related Technologies  Volume 36, 2013 - Issue 15 Pages 2166-2181

Nicardipine EP Impurity A (Oxalate salt) is chemically 2-[Benzyl(methyl)amino]ethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate oxalate (as per EP) ; 3-{2-[Benzyl(methyl)amino]ethyl}5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate oxalate (as per USP). It is also known as Nicardipine USP Related Compound B. Nicardipine EP Impurity A (Oxalate salt) is supplied with detailed characterization data compliant with regulatory guideline. Nicardipine EP Impurity A (Oxalate 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 Nicardipine.

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.