Dienogest EP Impurity I

Polarographic Investigation of Dienogest
Melek Sirin Baymak, z Hayati Celik, Nurgul K. Bakırhan, Bengi Uslu, and Sibel A. Ozkan
Journal of The Electrochemical Society, 165 (10) G128-G132 (2018)
 
Rapid high performance liquid chromatography method development with high prediction accuracy, using 5 cm long narrow bore columns packed with sub-2 m particles and Design Space computer modeling
Szabolcs Feketea,∗, Jeno Fekete ˝ b, Imre Molnár c, Katalin Ganzler
Journal of Chromatography A, 1216 (2009) 7816–7823
 
A Novel Liquid Chromatography Tandem Mass Spectrometric Method for the Determination of Dienogest in Bulk and Commercial Formulation
Abel jacob george1 , s. t. narenderan1 , s. n. meyyanathan1*, b. babu1 and m. kalaivani
Journal of Pharmaceutical Research and Therapeutics 2020; Volume 1 (Issue 01); 31-34
 
Validated Stability Indicating RP-hplc Method for the Assay of Dienogest in Bulk and Tablet Dosage Form
Avilas Bhatta, Kailash Bansal, Prashant Hedau, Kumud Padhee, Prithipal Singh Kochhar
International Journal of Pharmaceutical Quality Assurance; 4(2); 20-26

Dienogest EP Impurity I is chemically [17-Hydroxy-3-oxoestr-5(10)en-17α-yl]acetonitrile. Dienogest EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Dienogest EP Impurity I 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 Dienogest.

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.