Nifedipine EP Impurity B

Rapid characterization of impurities in the bulk drug of nifedipine by high performance liquid chromatography-quadrupole time of fight mass spectrometry
Peixi Zhu 1, Lixi Ding, Jiajia He, Guogang Zheng
Se Pu. 2012 Oct;30(10):1026-30.
 
Development and validation of rp-hplc method for the estimation of process related impurity from nifedipine
Dr.Manisha. S. Kedar1* , Dr.Manoj. P. Shirbhate2 , Manjusha. S. Sanap3 , Dr.Rani. S. Kankate4 , Prerana. B. Jadhav5 and Bhagyashri. J. Warude
European Journal of Molecular & Clinical Medicine Volume 7, Issue 8, 2020; 5593-5601
 
Validation of an HPLC Method for Nifedipine and its Related Substances in Raw Materials
N. Beaulieu ,N. M. Curran,S. J. Graham,R. W. Sears &E. G. Lovering
Journal of Liquid Chromatography  Volume 14, 1991 - Issue 6 Pages 1173-1183
 
Development and characterization of ethylcellulose based microsphere for sustained release of nifedipine
PatitapabanaParidaaSubash ChandraMishrabSubhashreeSahoocAjitBeheradBibhukalyan PrasadNayak
Journal of Pharmaceutical Analysis Volume 6, Issue 5, October 2016, Pages 341-344

Nifedipine EP Impurity B is chemically Dimethyl 4-(2-nitrosophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate ;. It is also known as Nifedipine Nitrosophenylpyridine analog (USP). Nifedipine EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Nifedipine EP Impurity B 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 Nifedipine.

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.