Ethinylestradiol EP Impurity B

Reversed-​phase high-​performance liquid chromatographic determination of Norethindrone acetate and ethinyl estradiol in pharmaceutical formulation
By Koneru, Ajitha; Kimbahune, Ritu; Mubeen, G.; Lalitha, N.; Chakraborty, Krishnasis
From Indo American Journal of Pharmaceutical Research (2015), 5(6), 2442-2449
 
Analytical method development and validation for simultaneous determination and quantification of Ethinyl Estradiol and Gestodene in combined tablet dosage form by RP-​HPLC
By Nautiyal, Kanchan; Ramakrishna, K.
From Journal of Chemical and Pharmaceutical Research (2014), 6(10), 74-80
 
Simultaneous determination of ethinyl estradiol and drospirenone in oral contraceptive by high performance liquid chromatography
By Silva, Viviane Benevenuti; Galdos, Angel Arturo Gaona; Mothe, Cintia Maria Alves; Pallastrelli, Michele Bacchi; Prado, Maria Segunda Aurora; Singh, Anil Kumar; Kedor-Hackmann, Erika Rosa Maria; Santoro, Maria Ines Rocha Miritello
From Brazilian Journal of Pharmaceutical Sciences (2013), 49(3), 521-528
 
New oxidative decomposition mechanism of estradiol through the structural characterization of a minute impurity and its degradants
By Beni, Zoltan; Hada, Viktor; Varga, Emese; Maho, Sandor; Aranyi, Antal; Szantay, Csaba, Jr.
From Journal of Pharmaceutical and Biomedical Analysis (2013), 78-79, 183-189

Ethinylestradiol EP Impurity B is chemically 19-Nor-17α-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol (as per EP) ; 19-Nor-17α-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol (as per USP). It is also known as Ethinyl Estradiol USP Related Compound B (as per USP) ; 9,11-Dehydro Ethynyl Estradiol. Ethinylestradiol EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Ethinylestradiol EP Impurity B 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 Ethinyl Estradiol .

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.