Fulvestrant EP Impurity B

Quantitative estimation of Fulvestrant injection 505(j) composition and impurities profile by capillary gas chromatography and HPLC-​PDA techniques
By Dongala, Thirupathi; Katari, Naresh Kumar; Marisetti, Vishnu Murthy; Jonnalagadda, Sreekantha B.
From Journal of the Iranian Chemical Society (2021), 18(6), 1443-1454
 
Development and validation of HPLC-​UV method for the estimation of fulvestrant in bulk drug
By Thummaluru, Rama Mohan Reddy; Gurrala, Srikanth
From Journal of Pharmacy Research (Mohali, India) (2016), 10(1), 21-24
 
Stability indicating HPLC method for the determination of fulvestrant in pharmaceutical formulation in comparison with linear sweep voltammetric method
By Atila, Alptug; Yilmaz, Bilal; Kadioglu, Yucel
From Iranian Journal of Pharmaceutical Research (2016), 15(3), 369-378
 

 

Fulvestrant EP Impurity B is chemically 7α-[9-[(4,4,5,5,5-pentafluoropentyl)sulfonyl]nonyl]estra-1,3,5(10)-triene-3,17β-diol (as per EP) ; 7α-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfonyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol (as per USP). It is also known as Fulvestrant 9-Sulfone. Fulvestrant EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Fulvestrant 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 Fulvestrant.

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.