Drospirenone EP Impurity H

Development and validation of new analytical method for simultaneous estimation of drospirenone and ethinyl estradiol
By Karajgi, S. R.; Mallikarjun, D. T.; Somashekhar, M.; Shivakumar, B.
From International Journal of ChemTech Research (2019), 12(5), 108-117
 
A simple and rapid validated stability indicating HPLC method for the determination of drospirenone in a pharmaceutical product
By Talath, Sirajunisa; Dhaneshwar, Sunil
From Indo American Journal of Pharmaceutical Research (2017), 7(1), 7401-7410

Drospirenone EP Impurity H is chemically 7β-(Chloromethyl)-3-oxo-15α,16α-dihydro-3′H-cyclopropa[15,16]pregn-4-ene-21,17-carbolactone (as per EP). It is also known as 3′-Chloro-3′,6-seco-17-epidrospirenone (EP) ; 7-Chloromethyl 17R-Drospirenone. Drospirenone EP Impurity H is supplied with detailed characterization data compliant with regulatory guideline. Drospirenone EP Impurity H 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 Drospirenone.

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.