Progesterone EP Impurity E

Column selection approach for related substances determination of progesterone by high‐performance liquid chromatography
Ying Huang  Hui Xiao  Yaxiong Liu  Jiaming Gan  Quanhong Yan
chemical biology and drug design Volume93, Issue1 January 2019 Pages 29-37
 
Characterization of Progesterone Derivatives by LC-DAD-ESI/MSn and Its Application to the Identification of Impurities in Flurogestone Acetate
Yufeng Zhang, Zunyuan Wang, Zhen Ma & Yiyu Cheng
Chromatographia volume 68, pages903–909(2008)
 
Fifty-year old samples of progesterone demonstrate the complex role of synthetic impurities in stabilizing a metastable polymorph
Robert W. Lancaster, Lisa D. Harris  and  David Pearson
CrystEngComm, 2011,13, 1775-1777
 
Analytical Method Development and Validation for the Estimation of Abiraterone and its Impurity in Pharmaceutical Formulation By RP-HPLC
Kuna AK * , Seru Ganapaty and Gadela V Radha
Der Pharmacia Lettre, 2018, 10 [9]: 19-31

Progesterone EP Impurity E is chemically (20R)-3-oxopregn-4-en-20-yl acetate ; (R)-1-((8S,9S,10R,13S,14S,17S)-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl)ethyl acetate. Progesterone EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Progesterone EP Impurity E 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 Progesterone.

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.