Fluorometholone Impurity 1

Validated HPTLC and HPLC methods for determination of fluorometholone and sodium cromoglycate in presence of their impurities and degradation products; application to kinetic study and on rabbit aqueous humor
Maha A. Hegazy, May H. Abdelwahab, Hassan A. M. Hendawy, Soheir A. Weshahy & Samah S. Abbas
Journal of Liquid Chromatography & Related Technologies  Volume 41, 2018 - Issue 5 Pages 203-222
 
Hplc method for determination of fluorometholone and sodium cromoglycate in bulk and ophthalmic solution
Hani M. Hafez, Abdulla A. Elshanawany, Lobna M. Abdelaziz, Mustafa S. Mohram
J App Pharm Vol. 7; Issue 1: 01-08; January, 2015
 

Fluorometholone Impurity 1 is chemically (6S,8S,9R,10S,11S,13S,14S,17R)-9-Fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one. It is also known as Fluorometholone 21-Hydroxy Analog. Fluorometholone Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Fluorometholone Impurity 1 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 Fluorometholone.

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.