Fluticasone Propionate EP Impurity B

Characterisation of impurities in bulk drug batches of fluticasone propionate using directly coupled HPLC–NMR spectroscopy and HPLC–MS
Nisha Mistry a , Ismail M. Ismail b , Marco S. Smith c , Jeremy K. Nicholson d , John C. Lindon
Journal of Pharmaceutical and Biomedical Analysis 16 (1997) 697–705

Fluticasone Propionate EP Impurity B is chemically 6α,9-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17-(propanoyloxy)androsta-1,4-dien-17β-carbo(thioperoxoic) SO-acid,. It is also known as Fluticasone USP Related Compound A ; Fluticasone Sulfenic Acid Propionate ; . Fluticasone Propionate EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Fluticasone Propionate 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 Fluticasone.

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.