Mirtazapine EP Impurity C

Determination of mirtazapine in spiked human plasma and tablets by first derivative spectrofluorimetric method
Rasha M.Youssef
Saudi Pharmaceutical Journal Volume 18, Issue 1, January 2010, Pages 45-49
 
Development and Validation of a Reversed-Phase HPLC Method for Separation and Simultaneous Determination of Process-Related Substances of Mirtazapine in Bulk Drugs and Formulations
R. Nageswara Rao* and A. Narasa Raju
Journal of Chromatographic Science, Vol. 47, March 2009; 223-230
 
Simultaneous Determination of Mirtazapine and its Three Main Impurities by a High Performance Thin Layer Chromatography/ Densitometry Method
T. Sheshashena Reddy and P. Sita Devi
Journal of Liquid Chromatography & Related Technologiesw, 31: 1204–1212, 2008

Mirtazapine EP Impurity C is chemically (14bRS)-2-methyl-3,4,10,14b-tetrahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-1(2H)-one (as per EP) ; 2-Methyl-3,4,10,14b-tetrahydrobenzo[c]pyrazino[1,2-a]pyrido[3,2-f]azepin-1(2H)-one (as per USP). It is also known as Mirtazapine USP Related Compound C ; Mirtazapine Lactam. Mirtazapine EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Mirtazapine EP Impurity C 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 Mirtazapine.

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.