Clobetasol Propionate EP Impurity J

Development and validation of a fast RP-​HPLC method for the determination of clobetasol propionate in topical nanocapsule suspensions
By Fontana M C; Bastos M O; Beck R C R
From Journal of chromatographic science (2010), 48(8), 637-40
 
Qualitative and quantitative assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream by HPLC-​TOF-​MS and HPLC
By Yang Wenling; Yang Xiaomei; Shi Fanghua; Wang Ruixun; Li Qing; Bi Kaishun; Liao Zhigang; Liang Yongkun; Yu Liangzhong
From Journal of pharmaceutical analysis (2019), 9(3), 156-162
 

Clobetasol Propionate EP Impurity J is chemically (17R)-4′-Chloro-5′-ethyl-9-fluoro-11β-hydroxy-16β-methylspiro[androsta-1,4-diene-17,2′(3′H)-furan]-3,3′-dione ( 17α-spiro compound) (as per EP); 9α-Fluoro-11β-hydroxy-16β-methyl 3-oxo-androsta-1,4-diene-17(R)-spiro-2′-[4′-chloro-5′-ethylfuran-3′(2′H)-one] (as per USP). It is also known as Clobetasol Propionate USP Related Compound A. Clobetasol Propionate EP Impurity J is supplied with detailed characterization data compliant with regulatory guideline. Clobetasol Propionate EP Impurity J 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 Clobetasol Propionate.

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.