Spironolactone EP Impurity I

RP- HPLC method for the simultaneous estimation of losartan and spironolactone in tablet dosage form
By Chaure, Pravin P.; Sigh, Sonia; Shariff, Arshia; Wagh, Vishalkumar H.; Tandale, Sandeep D.
From Journal of Pharmaceutical Sciences and Research (2019), 11(8), 2866-2871.
 
Design of experimental approach to analytical robustness study for UHPLC method developed for separation and quantification of spironolactone and its impurities in drug substances
By Veerendra, Y. V. S.; Brahman, Pradeep Kumar; Mankumare, Sharad D.; Ch, Jaya Raju; Satish, J.
From Asian Journal of Chemistry (2020), 32(2), 219-227.
 
Influence of different chromatographic conditions on the level of detection and quantitation of spironolactone by means of TLC-densitometry
By Dolowy, Malgorzata
From Journal of Analytical Methods in Chemistry (2019), 8792783/1-8792783/8.
 

Spironolactone EP Impurity I is chemically S-[17α-(Ethoxymethyl)-17β-hydroxy-3-oxoandrost-4-en-7α-yl] ethanethioate (as per EP); S-[17α-(Ethoxymethyl)-17-hydroxy-3-oxoandrost-4-en-7α-yl]ethanethioate (as per USP). It is also known as Spironolactone USP Related Compound I. Spironolactone EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Spironolactone 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 Spironolactone.

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.