Estradiol Valerate EP Impurity E

Validated RP-HPLC method for the determination of estradiol valerate in bulk and pharmaceutical formulations
M. Madhu1 *, Satyadev T. N. V. S. S.1 , G. Hephzibah1 and T. V. Reddy
Der Pharmacia Lettre, 2016, 8 (4):50-61
 
Determination of estradiol and its degradation products by liquid chromatography
Lucie Havlíková, Lucie Nováková, Ludmila Matysová, Jan Sícha
Journal of Chromatography A 1119(1-2):216-23
 
Determination of Related Substances in Estradiol Valerate Tablet by Use of HPLC Method
Du, Biying
Current Pharmaceutical Analysis, Volume 14, Number 5, 2018, pp. 513-518(6)

Estradiol Valerate EP Impurity E is chemically Estra-1,3,5(10)-trien-3,17β-diyl dipentanoate (as per EP) ; Estra-1,3,5(10)-trien-3,17β-diyl divalerate ( as per USP). It is also known as Estradiol divalerate. Estradiol Valerate EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Estradiol Valerate EP Impurity E 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 Estradiol Valerate.

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.