Estradiol Dimer 1

Effect of Impurities on Estradiol Crystallization in a Sustained-Release Implant
G. f. needham*’, R. r. pfeiffer’*, G. l. engel, S. rutherford, and D. j. allen
Journal of Pharmaceutical Sciences Volume 81, Issue 10, October 1992, Pages 1012-1014
 
HPLC Method for Simultaneous Determination of Potential Impurities of Norgestimate and Ethinyl Estradiol in Combination Drug Product Using Sub-2 µm Column
Bhaskara p. v. mantena,1 sumathi v. rao,1 k. m. ch. appa rao,2 k. ramakrishna,2 and s. p. vittal
Journal of Liquid Chromatography & Related Technologies, 38: 1014–1025, 2015
 
A validated simultaneous rp-hplc method for determination of desogestrel and ethinyl estradiol tablets
M sarat1, and c rambabu
Int J Pharm Pharm Sci, Vol 4, Suppl 5, 115-119
 
Rapid high performance liquid chromatography method development with high prediction accuracy, using 5 cm long narrow bore columns packed with sub-2 m particles and Design Space computer modeling
Szabolcs Feketea,∗, Jeno Fekete ˝ b, Imre Molnár c, Katalin Ganzler
Journal of Chromatography A, 1216 (2009) 7816–7823

Estradiol Dimer 1 is chemically (13S,17S)-4-(((13S,17S)-17-Hydroxy-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthren-3-yl)oxy)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol. Estradiol Dimer 1 is supplied with detailed characterization data compliant with regulatory guideline. Estradiol Dimer 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 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.