Prednisolone EP Impurity H

Validated stability indicating RP-​LC assay for determination of gatifloxacin and prednisolone acetatein ophthalmic preparations and biological samples
By Qadir, Muhammad A.; Shahzad, Shabnam; Ahmed, Mahmood; Razzaq, Syed S.; Shafiq, Muhmmad I.
From Latin American Journal of Pharmacy (2016), 35(5), 912-920
 
Novel stability indicating RP-​HPLC method for the simultaneous estimation of moxifloxacin and prednisolone in bulk and their combined dosage form
By Potnuri, Naga Raju; Rao, G. Devala; Prasad, Y. Rajendra
From International Journal of Pharmaceutical Sciences and Research (2015), 6(5), 1965-1973
 
Development and validation of a new stability indicating reversed phase liquid chromatographic method for the determination of prednisolone acetate and impurities in an ophthalmic suspension
By Marley, Adrian; Stalcup, Apryll M.; Connolly, Damian
From Journal of Pharmaceutical and Biomedical Analysis (2015), 102, 261-266
 

Prednisolone EP Impurity H is chemically 11β,17,21-Trihydroxypregna-1,4,6-triene-3,20-dione (as per EP). It is also known as Δ6-Prednisolone. Prednisolone EP Impurity H is supplied with detailed characterization data compliant with regulatory guideline. Prednisolone 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 Prednisolone.

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.